The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Accuflo Uf Control Module No. 74-0100-3.
| Device ID | K883490 |
| 510k Number | K883490 |
| Device Name: | ACCUFLO UF CONTROL MODULE NO. 74-0100-3 |
| Classification | Detector, Dialysate Level |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Contact | Del Donna |
| Correspondent | Del Donna NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Product Code | FJB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-09-29 |