CURALINE POLYURETHANE FOAM AWC DRESSING


Device Classification Name

dressing, wound, drug

510(k) Number K121361
Device Name CURALINE POLYURETHANE FOAM AWC DRESSING
Applicant
CURALINE INC
10554 north washington port road
mequon, 
WI 
53092

Applicant Contact haitham matloub
Correspondent
CURALINE INC
10554 north washington port road
mequon, 
WI 
53092

Correspodent Contact haitham matloub
Classification Product Code
FRO  
Date Received 05/07/2012
Decision Date 11/30/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No