The following data is part of a premarket notification filed by Colorado Medical, Inc. with the FDA for Modified Hr-3000 Reuse Adaptor.
| Device ID | K870471 |
| 510k Number | K870471 |
| Device Name: | MODIFIED HR-3000 REUSE ADAPTOR |
| Classification | Dialyzer Reprocessing System |
| 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 | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-04-10 |