The following data is part of a premarket notification filed by Colorado Medical, Inc. with the FDA for Adaptor Hr-3000 Reuse.
| Device ID | K841153 |
| 510k Number | K841153 |
| Device Name: | ADAPTOR HR-3000 REUSE |
| Classification | Dialyzer Reprocessing System |
| Applicant | COLORADO MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-07-16 |