The following data is part of a premarket notification filed by Colorado Therapeutics Llc with the FDA for Colorado Therapeutics Xenograft Implant.
| Device ID | K160181 |
| 510k Number | K160181 |
| Device Name: | COLORADO THERAPEUTICS XENOGRAFT IMPLANT |
| Classification | Mesh, Surgical |
| Applicant | Colorado Therapeutics LLC 2150 WEST 6TH AVENUE SUITE L Broomfield, CO 80020 |
| Contact | William Jackson |
| Correspondent | William Jackson Colorado Therapeutics LLC 2150 WEST 6TH AVENUE SUITE L Broomfield, CO 80020 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-10-20 |
| Summary: | summary |