Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K982532 |
FOIA Releasable 510(k) |
K982532
|
Device Name |
PARIETEX |
Applicant |
COGENT |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
COGENT |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/20/1998 |
Decision Date | 01/20/1999 |
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
|