Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K080691 |
Device Name |
C-QUR EDGE MESH V-PATCH |
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 | 03/11/2008 |
Decision Date | 04/16/2008 |
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
|