The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Minisling Adjustable Polymer Sling & Surgical Mesh With Self-anchoring System.
| Device ID | K070846 |
| 510k Number | K070846 |
| Device Name: | MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-28 |
| Decision Date | 2007-07-02 |
| Summary: | summary |