The following data is part of a premarket notification filed by Mesa Medical, Inc. with the FDA for Recommended Alternative Dialyzer Disinfectant.
| Device ID | K852749 |
| 510k Number | K852749 |
| Device Name: | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | MESA MEDICAL, INC. 3904 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Paul D Duke |
| Correspondent | Paul D Duke MESA MEDICAL, INC. 3904 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-27 |
| Decision Date | 1985-09-10 |