The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Tendon Wrap.
| Device ID | K080452 |
| 510k Number | K080452 |
| Device Name: | COLLAGEN TENDON WRAP |
| Classification | Mesh, Surgical |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes, NJ 07417 |
| Contact | Peggy Hansen |
| Correspondent | Peggy Hansen COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes, NJ 07417 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813954020730 | K080452 | 000 |
| 00813954020723 | K080452 | 000 |
| 00813954020716 | K080452 | 000 |
| 00813954020709 | K080452 | 000 |
| 00813954020693 | K080452 | 000 |
| 00813954020686 | K080452 | 000 |
| 00813954025735 | K080452 | 000 |
| 00813954025728 | K080452 | 000 |