The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Hollow Fiber Dialyzer Focus 9or/90h-r/120r/120h-r.
| Device ID | K914790 |
| 510k Number | K914790 |
| Device Name: | HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| 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 | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-23 |
| Decision Date | 1993-03-05 |