The following data is part of a premarket notification filed by Colorado Medical, Inc. with the FDA for Colorado Medical Model Ptc 1000.
| Device ID | K863471 |
| 510k Number | K863471 |
| Device Name: | COLORADO MEDICAL MODEL PTC 1000 |
| Classification | System Accessories, Extracorporeal |
| Applicant | COLORADO MEDICAL, INC. BERGEN PARK BUSINESS PLAZA 1202 HIGHWAY 74, SUITE 109 Evergreen, CO 80439 |
| Contact | Thomas E Jones |
| Correspondent | Thomas E Jones COLORADO MEDICAL, INC. BERGEN PARK BUSINESS PLAZA 1202 HIGHWAY 74, SUITE 109 Evergreen, CO 80439 |
| Product Code | KXM |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-10-02 |