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 Series Focus 160/160h.
| Device ID | K895759 |
| 510k Number | K895759 |
| Device Name: | HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| 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 | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-11-08 |