Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K121070 |
Device Name |
C-QUR RPM MESH |
Applicant |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR |
HUDSON,
NH
03051
|
|
Applicant Contact |
JOSEPH DEPAOLO |
Correspondent |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR |
HUDSON,
NH
03051
|
|
Correspondent Contact |
JOSEPH DEPAOLO |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/09/2012 |
Decision Date | 04/26/2012 |
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
|