DUKAL NON ADHERENT DRESSING

Gauze/sponge, Internal

DUKAL CORP.

The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Non Adherent Dressing.

Pre-market Notification Details

Device IDK970455
510k NumberK970455
Device Name:DUKAL NON ADHERENT DRESSING
ClassificationGauze/sponge, Internal
Applicant DUKAL CORP. 40178 U.S. 19 NORTH Tarpon Springs,  FL  34689
ContactPatrick Lamb
CorrespondentPatrick Lamb
DUKAL CORP. 40178 U.S. 19 NORTH Tarpon Springs,  FL  34689
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-06
Decision Date1997-05-08
Summary:summary

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