Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K070192 |
Device Name |
ATRIUM PROLITE ULTRA S 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 | 01/22/2007 |
Decision Date | 03/08/2007 |
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
|