Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K070846 |
Device Name |
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM |
Applicant |
PROSURG, INC. |
2193 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
ASHVIN DESAI |
Correspondent |
PROSURG, INC. |
2193 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
ASHVIN DESAI |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/28/2007 |
Decision Date | 07/02/2007 |
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
|