The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Mtf Fascia.
| Device ID | K120479 |
| 510k Number | K120479 |
| Device Name: | MTF FASCIA |
| Classification | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -5794 |
| Contact | Randy Prebula |
| Correspondent | Randy Prebula MUSCULOSKELETAL TRANSPLANT FOUNDATION 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -5794 |
| Product Code | OWY |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-16 |
| Decision Date | 2012-11-08 |
| Summary: | summary |