The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Rapid Disconnect Y-set, Cat. No. 48-7000.
| Device ID | K930843 |
| 510k Number | K930843 |
| Device Name: | RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Contact | Morton S Lefar |
| Correspondent | Morton S Lefar 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 | 1993-02-18 |
| Decision Date | 1994-08-31 |