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, Bio Care Ps 130.
| Device ID | K900018 |
| 510k Number | K900018 |
| Device Name: | HOLLOW FIBER DIALYZER, BIO CARE PS 130 |
| 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 | 1990-01-02 |
| Decision Date | 1990-07-27 |