The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Focua 90r, 90hr, 120r, 120hr, 160r, 160hr Hollow Fiber Dialyzer.
| Device ID | K952343 |
| 510k Number | K952343 |
| Device Name: | FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. 2 VOLVO DR. Rockleigh, NJ 07647 |
| Contact | Debra L Bing |
| Correspondent | Debra L Bing NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. 2 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 | 1995-05-19 |
| Decision Date | 1995-12-22 |