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
|
|
Correspondent Contact |
HAITHAM MATLOUB |
Classification Product Code |
|
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
|
|
|