The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Modified Labeling To Model 9608 Arterial Hemo Bld..
| Device ID | K895244 |
| 510k Number | K895244 |
| Device Name: | MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD. |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02154 |
| Contact | Berger, Phd |
| Correspondent | Berger, Phd NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02154 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-21 |
| Decision Date | 1990-02-12 |