The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Peritoneal Dialysis Cycler Set.
| Device ID | K914363 |
| 510k Number | K914363 |
| Device Name: | PERITONEAL DIALYSIS CYCLER SET |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Contact | Robert Bishop |
| Correspondent | Robert Bishop NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1992-03-16 |