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 48-3028-9.
| Device ID | K920693 |
| 510k Number | K920693 |
| Device Name: | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 |
| Classification | Dialyzer, Parallel Flow |
| 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 | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-14 |
| Decision Date | 1992-09-21 |