FIBRACOL COLLAGEN-ALGINATE DRESSING

Syringe, Piston

JOHNSON & JOHNSON MEDICAL, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Fibracol Collagen-alginate Dressing.

Pre-market Notification Details

Device IDK925548
510k NumberK925548
Device Name:FIBRACOL COLLAGEN-ALGINATE DRESSING
ClassificationSyringe, Piston
Applicant JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington,  TX  76004 -3130
ContactWendt
CorrespondentWendt
JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington,  TX  76004 -3130
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-03
Decision Date1993-07-13

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