MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING

Dressing, Wound, Collagen

COLLAGEN MATRIX, INC.

The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Modification To: Collagen Topical Wound Dressing.

Pre-market Notification Details

Device IDK040211
510k NumberK040211
Device Name:MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
ClassificationDressing, Wound, Collagen
Applicant COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,,  NJ  07417
ContactPeggy Hansen
CorrespondentPeggy Hansen
COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,,  NJ  07417
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-30
Decision Date2004-02-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.