The following data is part of a premarket notification filed by Advanced Surgical Innovations, Inc. with the FDA for Prolex Mesh.
| Device ID | K960219 |
| 510k Number | K960219 |
| Device Name: | PROLEX MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ADVANCED SURGICAL INNOVATIONS, INC. 6890 PACIFIC CIRCLE Mississauga, Ontario, CA L5tin8 |
| Contact | David M Olsen |
| Correspondent | David M Olsen ADVANCED SURGICAL INNOVATIONS, INC. 6890 PACIFIC CIRCLE Mississauga, Ontario, CA L5tin8 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-03-15 |