The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Formalin Reuse Cart.
| Device ID | K941757 |
| 510k Number | K941757 |
| Device Name: | FORMALIN REUSE CART |
| Classification | Dialyzer Reprocessing System |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02154 |
| Contact | Paul Genoa |
| Correspondent | Paul Genoa NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02154 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-08 |
| Decision Date | 1996-01-22 |