The following data is part of a premarket notification filed by International Medical Products, Inc. with the FDA for Nikkiso Nk Pump.
| Device ID | K920077 |
| 510k Number | K920077 |
| Device Name: | NIKKISO NK PUMP |
| Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Applicant | INTERNATIONAL MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Contact | Jeffrey Shideman |
| Correspondent | Jeffrey Shideman INTERNATIONAL MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Product Code | DWD |
| CFR Regulation Number | 870.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-08 |
| Decision Date | 1993-09-29 |