The following data is part of a premarket notification filed by Novonx, Inc. with the FDA for Multi-centrifuge.
| Device ID | K955795 |
| 510k Number | K955795 |
| Device Name: | MULTI-CENTRIFUGE |
| Classification | Centrifuge, Hematocrit |
| Applicant | NOVONX, INC. 2257 SOUTH 11000 EAST SUITE 1A Salt Lake City, UT 84106 |
| Contact | Glen S Putnam |
| Correspondent | Glen S Putnam NOVONX, INC. 2257 SOUTH 11000 EAST SUITE 1A Salt Lake City, UT 84106 |
| Product Code | GKG |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-03-29 |
| Summary: | summary |