Flowmeter, Blood, Cardiovascular

FDA product code DPW · 135 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2100
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-13 – 2026-07-08

DPW 2026-07-08

BlueDop Vascular Expert

Applicant BlueDop Medical, Ltd.

K number K260700

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DPW 2026-04-24

FloPatch FP120

Applicant Flosonics Medical

K number K252810

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DPW 2025-11-20

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)

Applicant Remington Medical, Inc.

K number K251904

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DPW 2025-06-20

FloPatch FP120

Applicant Flosonics Medical

K number K251114

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DPW 2025-04-14

Elfor-L

Applicant Elfi-Tech , Ltd.

K number K243852

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DPW 2024-08-30

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)

Applicant Remington Medical, Inc.

K number K241583

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DPW 2023-05-03

FloPatch FP120

Applicant Flosonics Medical

K number K223843

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DPW 2022-12-09

FloPatch FP120

Applicant Flosonics Medical

K number K222242

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DPW 2022-04-20

GEM FLOW COUPLER Monitor (GEM1020M-2)

Applicant Synovis Micro Companies Alliance, Inc.

K number K213974

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DPW 2022-01-27

VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger

Applicant Remington Medical, Inc.

K number K211589

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DPW 2021-10-07

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger

Applicant Remington Medical, Inc.

K number K212065

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DPW 2021-01-05

Bidop 7

Applicant Koven Technology, Inc.

K number K201114

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DPW 2020-03-24

FloPatch (FP120)

Applicant Flosonics Medical (R/A 1929803 Ontario Corp.)

K number K200337

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DPW 2020-01-10

FlowMet

Applicant Laser Associated Sciences, Inc.

K number K192966

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DPW 2019-09-06

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes

Applicant Huntleigh Healthcare , Ltd.

K number K183574

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DPW 2019-06-21

FloPatch (FP110)

Applicant Flosonics Medical (R/A 1929803 Ontario Corp.)

K number K191388

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DPW 2019-02-27

FlowMet-R

Applicant Laser Associated Sciences, Inc.

K number K182494

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DPW 2018-12-14

iCertainty

Applicant Rfpi

K number K181269

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DPW 2018-06-28

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

Applicant Deltex Medical Limited

K number K172457

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DPW 2016-05-05

PeriFlux6000

Applicant Perimed AB

K number K152930

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DPW 2013-10-10

DELTEX MEDICAL CARDIOQ-EDM+

Applicant Deltex Medical Limited

K number K132139

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DPW 2013-09-13

CEROX

Applicant Or-Nim Medical , Ltd.

K number K131854

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DPW 2012-01-06

SONOTT FLOWLAB(R)

Applicant Em-Tec GmbH

K number K111730

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DPW 2011-12-21

AUREFLO MONITORING SYSTEM

Applicant Transonic Systems, Inc.

K number K112657

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DPW 2011-10-20

DELTEX MEDICAL CARDIOQ EDM

Applicant Deltex Medical Limited

K number K111542

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DPW 2011-05-04

SENSILASE PAD-IQ

Applicant Vasamed, Inc.

K number K110438

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DPW 2011-03-16

DOPPLER MONITOR

Applicant Cook Vascular, Inc.

K number K110347

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DPW 2010-12-27

MEDISTIM VERIQC SYSTEM

Applicant Medi-Stim Asa

K number K102595

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DPW 2010-11-18

MOORVMS-PRES PRESSURE CUFF CONTROLLER

Applicant Moor Instruments, Ltd.

K number K102433

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DPW 2008-10-28

VTI INTRAOPERATIVE DOPPLER SYSTEMS

Applicant Vascular Technology Incorporated

K number K082870

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DPW 2007-02-28

CRITIVIEW, MODEL CRV3

Applicant Critisense , Ltd.

K number K062977

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DPW 2006-01-18

CRITIVIEW

Applicant Critisense , Ltd.

K number K051145

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DPW 2005-09-06

VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01

Applicant Vascular Control Systems, Inc.

K number K052209

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DPW 2005-04-15

SMARTDOP 45 VASCULAR DOPPLER

Applicant Koven Technology, Inc.

K number K050601

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DPW 2005-02-08

QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER

Applicant Neoprobe Corp.

K number K050088

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DPW 2004-06-07

QUANTIX OR VESSEL STABILIZER DEVICE

Applicant Cardiosonix, Ltd.

K number K041180

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DPW 2004-06-04

SENSILASE PAD 3000

Applicant Optical Sensors, Inc.

K number K040654

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DPW 2004-04-29

MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122

Applicant Medi-Stim A/S

K number K040228

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DPW 2004-04-20

SONO TT ULTRASONIC FLOWCOMPUTER

Applicant Em-Tec GmbH

K number K040909

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DPW 2004-02-13

ECHO SOUNDER EX-101EX 8 MHZ

Applicant Koven Technology, Inc.

K number K031931

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DPW 2003-12-11

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002

Applicant Transonic Systems, Inc.

K number K033424

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DPW 2003-11-25

MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065

Applicant Arrow Intl., Inc.

K number K031153

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DPW 2003-08-20

QUANTIX/OR DEVICE

Applicant Cardiosonix, Ltd.

K number K030357

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DPW 2003-08-06

CARDIOQ, MODEL 9051-7005

Applicant Deltex Medical

K number K031706

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DPW 2003-05-14

CAPIOX CARDIOTOMY RESERVOIR

Applicant Terumo Cardiovascular Systems Corp.

K number K030505

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DPW 2003-04-23

VTI 20 MHZ GATED DOPPLER

Applicant Vascular Technology Incorporated

K number K031091

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DPW 2002-11-13

QUANTIX/ND DEVICE

Applicant Cardiosonix, Ltd.

K number K023431

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DPW 2002-05-08

QFLOW 500 PERFUSION MONITORING SYSTEM

Applicant Hemedex Incorporated

K number K013376

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DPW 2002-02-13

FLOWGUARD DEVICE

Applicant Biosonix , Ltd.

K number K013803

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DPW 2002-02-12

BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T

Applicant Koven Technology, Inc.

K number K010452

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DPW 2001-11-06

PF 5050 PRESSURE UNIT, MODEL PF 5050

Applicant Perimed AB

K number K011899

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DPW 2001-05-02

VASCULAR ASSIST

Applicant Huntleigh Healthcare, Inc.

K number K002186

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DPW 2000-11-17

TISSUE SPECTROSCOPE

Applicant Vital Medical , Ltd.

K number K992529

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DPW 1999-08-19

JOSTRA HL-20 TWIN PUMP

Applicant Jostra Bentley

K number K984338

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DPW 1999-08-03

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200

Applicant Rossmax International , Ltd.

K number K992388

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DPW 1999-08-03

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100

Applicant Rossmax International , Ltd.

K number K992387

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DPW 1999-05-20

WRIST BLOOD PRESSURE METER MODEL SE-330

Applicant Sein Electronics Co., Ltd.

K number K973078

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DPW 1998-11-24

TUBING BLOOD FLOW METER MODEL NUMBER HD-800

Applicant Koven Technology, Inc.

K number K982986

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DPW 1998-10-14

VGF-7 VASCULAR GRAFT FLOWMETER

Applicant Medicard , Ltd.

K number K973198

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DPW 1998-05-28

PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT

Applicant Perimed, Inc.

K number K974285

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DPW 1998-04-30

MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR

Applicant Micro Weiss Electronics

K number K970211

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DPW 1998-04-30

MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO

Applicant Micro Weiss Electronics

K number K970139

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DPW 1998-03-13

MS-700

Applicant Alan S. Lee

K number K972213

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DPW 1998-02-24

DYNEMO 3000

Applicant Sometec, Inc.

K number K972798

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DPW 1996-03-29

BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY

Applicant Koven Technology, Inc.

K number K954397

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DPW 1995-11-07

EDM

Applicant Deltex Medical

K number K951369

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DPW 1995-06-29

MODEL PV2000 VASCULAR MICROLABORATORY

Applicant Vasamedics, LLC

K number K951486

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DPW 1994-12-23

SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR

Applicant Koven Technology, Inc.

K number K942613

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DPW 1993-12-07

PERITEMP PF 4005 HEATER

Applicant Perimed, Inc.

K number K932068

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DPW 1993-10-12

P/METER

Applicant Zertl Medical, Inc.

K number K921377

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DPW 1993-09-16

MS DISPOSABLE RIGID DOPPLER PROBE

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K930227

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DPW 1993-08-23

CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)

Applicant Cardio Metrics, Inc.

K number K925524

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DPW 1993-05-18

LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER

Applicant Titronics Medical Instruments, Inc.

K number K922034

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DPW 1993-02-03

PERIFLUX PF4001 LASER DOPPLER FLOWMETER

Applicant Perimed, Inc.

K number K922368

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DPW 1993-01-29

MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW

Applicant Koven and Assoc., Inc.

K number K922669

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DPW 1993-01-22

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR

Applicant Koven and Assoc., Inc.

K number K920333

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DPW 1992-12-10

MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR

Applicant Koven and Assoc., Inc.

K number K915550

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DPW 1992-07-21

PIM 1.0 LASER DOPPLER PERFUSION IMAGER

Applicant Lisca Development AB

K number K920844

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DPW 1992-01-09

ABCOM 2000

Applicant Applied Biometrics, Inc.

K number K912562

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DPW 1991-12-12

MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2

Applicant Vasamedics, LLC

K number K912446

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DPW 1991-11-19

MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG

Applicant Hewlett-Packard Co.

K number K913827

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DPW 1991-08-13

LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)

Applicant Vasamedics, LLC

K number K911763

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DPW 1991-04-29

INTERSPEC APOGEE, MODIFICATION

Applicant Interspec, Inc.

K number K910049

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DPW 1991-03-29

FLOWIRE AND FLOMAP

Applicant Cardio Metrics, Inc.

K number K905411

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DPW 1991-02-26

ES-1000SP II SMART DOP

Applicant Koven and Assoc., Inc.

K number K903026

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DPW 1991-02-13

AVALON GENERAL PURPOSE SCANNER, PREVIEW GP

Applicant Avalon Technology Corp.

K number K904317

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DPW 1991-01-28

DIAGNOSTIC ULTRASOUND VERSADOPP 1000

Applicant Diagnostic Ultrasound Corp.

K number K904792

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DPW 1990-11-07

DOPPLER NEEDLE AND FLOW MONITOR

Applicant Peripheral Systems Group

K number K903625

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DPW 1990-11-05

WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC

Applicant Wright Medical Corp.

K number K901015

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DPW 1990-10-09

ADVANCE LASER FLOWMETER, ALF 21

Applicant Transonic Systems, Inc.

K number K903633

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DPW 1990-08-10

ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER

Applicant Ge Medical Systems Information Technologies

K number K901335

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DPW 1990-08-08

MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND

Applicant Hewlett-Packard Co.

K number K902088

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DPW 1990-07-16

MODIFIED FLOCATH PULMONARY ARTERY CATHETER

Applicant Cardio Metrics, Inc.

K number K901733

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DPW 1990-02-16

FLAT VASCULAR PROBE

Applicant Imex Medical Systems, Inc.

K number K896613

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DPW 1990-02-13

LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2

Applicant Tsi, Inc.

K number K896515

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DPW 1990-01-19

NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.

Applicant Nihon Kohden America, Inc.

K number K894631

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DPW 1989-07-28

DVM-4200 BLOOD FLOWMETER

Applicant Koven and Assoc., Inc.

K number K892707

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DPW 1989-06-20

PERIFLUX PF3

Applicant Perimed, Inc.

K number K890828

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DPW 1988-11-07

IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER

Applicant Imex Medical Systems, Inc.

K number K882138

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DPW 1988-09-19

MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A

Applicant Tsi, Inc.

K number K875179

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