AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING


Device Classification Name

dressing, wound, drug

510(k) Number K080383
Device Name AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.
200 headquarters park dr.
skillman, 
NJ 
08558

Applicant Contact marilyn konicky
Correspondent
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.
200 headquarters park dr.
skillman, 
NJ 
08558

Correspodent Contact marilyn konicky
Classification Product Code
FRO  
Date Received 02/12/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes