The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Advanced Performance Hollow Fiber Dialyzer.
| Device ID | K861916 |
| 510k Number | K861916 |
| Device Name: | ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Contact | Del Donna |
| Correspondent | Del Donna 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 | 1986-05-19 |
| Decision Date | 1986-07-10 |