Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K090909 |
Device Name |
C-QUR V -PATCH MESH |
Applicant |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. |
HUDSON,
NH
03051
|
|
Applicant Contact |
JOSEPH P DE PAOLO |
Correspondent |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. |
HUDSON,
NH
03051
|
|
Correspondent Contact |
JOSEPH P DE PAOLO |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/01/2009 |
Decision Date | 06/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|