ACELL UBM HYDRATED WOUND DRESSING

Dressing, Wound, Collagen

ACELL, INC

The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Ubm Hydrated Wound Dressing.

Pre-market Notification Details

Device IDK022854
510k NumberK022854
Device Name:ACELL UBM HYDRATED WOUND DRESSING
ClassificationDressing, Wound, Collagen
Applicant ACELL, INC 815 CONNECTICUT AVE NW SUITE 800 Washington,  DC  20006
ContactPatsy J Trisler
CorrespondentPatsy J Trisler
ACELL, INC 815 CONNECTICUT AVE NW SUITE 800 Washington,  DC  20006
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-15
Decision Date2002-12-30
Summary:summary

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