Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K133889 |
Device Name |
PREMIUM |
Applicant |
COUSIN BIOTECH S.A.S. |
8 RUE DE L ABBE BONPAIN |
ALLEE DES ROSES |
WERVICQ-SUD,
FR
59117
|
|
Applicant Contact |
FRANCK PELLETIER |
Correspondent |
COUSIN BIOTECH S.A.S. |
8 RUE DE L ABBE BONPAIN |
ALLEE DES ROSES |
WERVICQ-SUD,
FR
59117
|
|
Correspondent Contact |
FRANCK PELLETIER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/20/2013 |
Decision Date | 09/04/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|