The following data is part of a premarket notification filed by Rti Biologics, Inc. with the FDA for Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358.
| Device ID | K091142 |
| 510k Number | K091142 |
| Device Name: | TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 |
| Classification | Mesh, Surgical |
| Applicant | RTI BIOLOGICS, INC. 11621 RESEARCH CIRCLE P.O. BOX 2650 Alachua, FL 32616 -1627 |
| Contact | Travis Arola |
| Correspondent | Travis Arola RTI BIOLOGICS, INC. 11621 RESEARCH CIRCLE P.O. BOX 2650 Alachua, FL 32616 -1627 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-08-31 |
| Summary: | summary |