Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K050311 |
Device Name |
ATRIUM MEDICAL CORPORATION C-QUR 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 | 02/08/2005 |
Decision Date | 03/31/2006 |
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
|
Recalls |
CDRH Recalls
|