The following data is part of a premarket notification filed by Injectx, Inc. with the FDA for Biosling - Bioabsorbable Polymer Sling & Surgical Mesh.
| Device ID | K010533 |
| 510k Number | K010533 |
| Device Name: | BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | INJECTX, INC. 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai INJECTX, INC. 2195 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 | 2001-02-23 |
| Decision Date | 2001-05-24 |