The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for 3i Model(s)7426 And 7427 Celsep Centrifuge System.
| Device ID | K994148 |
| 510k Number | K994148 |
| Device Name: | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | William G Conety |
| Correspondent | William G Conety IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-08 |
| Decision Date | 2000-02-01 |
| Summary: | summary |