The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Dextrolyte Ii, Peritoneal Dialysis Cycler Set -(8).
| Device ID | K896599 |
| 510k Number | K896599 |
| Device Name: | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8) |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Contact | John R Trembley |
| Correspondent | John R Trembley NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1990-03-22 |