The following data is part of a premarket notification filed by Rotation Medical, Inc. with the FDA for Collagen Tendon Sheet-d.
| Device ID | K122048 |
| 510k Number | K122048 |
| Device Name: | COLLAGEN TENDON SHEET-D |
| Classification | Mesh, Surgical |
| Applicant | ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 Plymouth, MN 55447 |
| Contact | Jeff Sims |
| Correspondent | Jeff Sims ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 Plymouth, MN 55447 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-12 |
| Decision Date | 2013-01-08 |
| Summary: | summary |