GAUZE CONVERSION CLASS I-NON-STERILE

Gauze/sponge, Internal

WINN HIRSCH & ASSOC.

The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Gauze Conversion Class I-non-sterile.

Pre-market Notification Details

Device IDK832214
510k NumberK832214
Device Name:GAUZE CONVERSION CLASS I-NON-STERILE
ClassificationGauze/sponge, Internal
Applicant WINN HIRSCH & ASSOC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-12
Decision Date1983-07-26

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