The following data is part of a premarket notification filed by Rti Biologics, Inc. with the FDA for Tutopatch, Tutomesh.
| Device ID | K081538 |
| 510k Number | K081538 |
| Device Name: | TUTOPATCH, TUTOMESH |
| 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 |
| Subsequent Product Code | DXZ |
| Subsequent Product Code | OXH |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2008-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14041543313496 | K081538 | 000 |
| 04041543311853 | K081538 | 000 |
| 04041543311860 | K081538 | 000 |
| 04041543311877 | K081538 | 000 |
| 04041543311884 | K081538 | 000 |
| 04041543311891 | K081538 | 000 |
| 04041543311907 | K081538 | 000 |
| 04041543311914 | K081538 | 000 |
| 04041543311921 | K081538 | 000 |
| 04041543311945 | K081538 | 000 |
| 04041543311952 | K081538 | 000 |
| 04041543311969 | K081538 | 000 |
| 04041543311976 | K081538 | 000 |
| 14041543313472 | K081538 | 000 |
| 14041543313489 | K081538 | 000 |
| 04041543311846 | K081538 | 000 |