The following data is part of a premarket notification filed by Colorado Therapeutics Llc with the FDA for Colorado Therapeutics Xenograft Implant.
| Device ID | K172937 |
| 510k Number | K172937 |
| Device Name: | Colorado Therapeutics Xenograft Implant |
| Classification | Mesh, Surgical |
| Applicant | Colorado Therapeutics LLC 2150 West 6th Avenue, Suite L Bloomfield, CA 80020 |
| Contact | William Jackson |
| Correspondent | William Jackson Colorado Therapeutics LLC 2150 West 6th Avenue, Suite L Bloomfield, CA 80020 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2017-10-25 |
| Summary: | summary |