BILAYER MATRIX WOUND DRESSING


Device Classification Name

dressing, wound, drug

510(k) Number K021792
Device Name BILAYER MATRIX WOUND DRESSING
Original Applicant
INTEGRA LIFESCIENCES CORP.
311 enterprise dr.
plainsboro, 
NJ 
08536

Original Contact diana m bordon
Classification Product Code
FRO  
Date Received 05/31/2002
Decision Date 08/14/2002
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls