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 Pump.
| Device ID | K915628 |
| 510k Number | K915628 |
| Device Name: | DEXTROLYTE II PERITONEAL DIALYSIS PUMP |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| 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 | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-17 |
| Decision Date | 1992-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861101112 | K915628 | 000 |