EXTRA LARGE COMPRESS DRESSING

Gauze/sponge, Internal

CERTIFIED SAFETY MFG., INC.

The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for Extra Large Compress Dressing.

Pre-market Notification Details

Device IDK940351
510k NumberK940351
Device Name:EXTRA LARGE COMPRESS DRESSING
ClassificationGauze/sponge, Internal
Applicant CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City,  MO  64127
ContactHoward Gerson
CorrespondentHoward Gerson
CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City,  MO  64127
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-25
Decision Date1994-02-25

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