Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K980483 |
Device Name |
MENTOR SUSPEND SLING |
Applicant |
MENTOR CORP. |
5425 HOLLISTER AVE. |
SANTA BARBARA,
CA
93111
|
|
Applicant Contact |
DONNA A CRAWFORD |
Correspondent |
MENTOR CORP. |
5425 HOLLISTER AVE. |
SANTA BARBARA,
CA
93111
|
|
Correspondent Contact |
DONNA A CRAWFORD |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/09/1998 |
Decision Date | 04/30/1998 |
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
|