Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K103682 |
Device Name |
PARIETEX PROGRIP |
Applicant |
SOFRADIM PRODUCTION |
15 CROSBY DRIVE |
BEDFORD,
MA
01730
|
|
Applicant Contact |
JAMES MCMAHON |
Correspondent |
SOFRADIM PRODUCTION |
15 CROSBY DRIVE |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
JAMES MCMAHON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/17/2010 |
Decision Date | 03/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|