The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Tendon Wrap Tendon Protector.
| Device ID | K053655 |
| 510k Number | K053655 |
| Device Name: | TENDON WRAP TENDON PROTECTOR |
| Classification | Mesh, Surgical |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Diana M Bordon |
| Correspondent | Diana M Bordon INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-30 |
| Decision Date | 2006-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269TG4511 | K053655 | 000 |
| M269TG2211 | K053655 | 000 |