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FDA 510(k)

TZ

K-Number: K964777 · 1997-01-03

ApplicantGallini Intl., Inc.
Decision Date1997-01-03
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TZ is the device name listed in this FDA 510(k) record. The listed applicant is Gallini Intl., Inc.. It received FDA 510(k) clearance on 1997-01-03 under 510(k) number K964777. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TZ?

TZ is a medical device that received FDA 510(k) clearance on 1997-01-03. The listed applicant is Gallini Intl., Inc.. The 510(k) number is K964777.

When did TZ receive FDA 510(k) clearance?

TZ received FDA 510(k) clearance on 1997-01-03, under 510(k) number K964777.

Who is the listed applicant for TZ?

The FDA 510(k) record lists Gallini Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TZ?

The FDA product code for TZ is KNW.

Other records listing Gallini Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970872PAN (CHIBA ASPIRATING NEEDLE)K970871TR NEEDLEK962570ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLEK962569BIOMID BONE MARROW BIOPSY NEEDLEK962568ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLESK961407SPEED-CUT

View all 7 devices →

Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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