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FDA 510(k)

REPROCESSED COMPRESSION SLEEVES

K-Number: K100909 · 2010-07-23

ApplicantAscent Healthcare Solutions
Decision Date2010-07-23
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REPROCESSED COMPRESSION SLEEVES is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Healthcare Solutions. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K100909. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED COMPRESSION SLEEVES?

REPROCESSED COMPRESSION SLEEVES is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Ascent Healthcare Solutions. The 510(k) number is K100909.

When did REPROCESSED COMPRESSION SLEEVES receive FDA 510(k) clearance?

REPROCESSED COMPRESSION SLEEVES received FDA 510(k) clearance on 2010-07-23, under 510(k) number K100909.

Who is the listed applicant for REPROCESSED COMPRESSION SLEEVES?

The FDA 510(k) record lists Ascent Healthcare Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED COMPRESSION SLEEVES?

The FDA product code for REPROCESSED COMPRESSION SLEEVES is JOW.

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Other records listing Ascent Healthcare Solutions 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.

K111600REPROCESSED HAND ACTIVATE SEALER/DIVIDERK110189REPROCESSED ELECTROSURGICAL INSTRUMENTK100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERK100537REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUEK100080REPROCESSED TROCARS, MODEL B5LT AND CB5LTK093702REPROCESSED ULTRASONIC COAGULATING SHEARS

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Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

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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