MEPILEX AG DRESSING

Device Classification Name

dressing, wound, drug

510(k) Number K071354
Device Name MEPILEX AG DRESSING
Applicant
MONLYCKE HEALTH CARE
5550 peachtree pkwy.
suite 500
norcross, 
GA 
30092

Applicant Contact steven dowdley
Correspondent
MONLYCKE HEALTH CARE
5550 peachtree pkwy.
suite 500
norcross, 
GA 
30092

Correspodent Contact steven dowdley
Classification Product Code
FRO  
Date Received 05/15/2007
Decision Date 07/13/2007
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes