The following data is part of a premarket notification filed by Perfusion Partners & Assoc. Inc. with the FDA for Genesiscs Component Concentrating System.
| Device ID | K070666 |
| 510k Number | K070666 |
| Device Name: | GENESISCS COMPONENT CONCENTRATING SYSTEM |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | PERFUSION PARTNERS & ASSOC. INC. 1970 N. LESLIE RD., NO 220 Pahrump, NV 89060 |
| Contact | Nancy Lord Md. Esq |
| Correspondent | Nancy Lord Md. Esq PERFUSION PARTNERS & ASSOC. INC. 1970 N. LESLIE RD., NO 220 Pahrump, NV 89060 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2007-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855306003466 | K070666 | 000 |
| 00855306003275 | K070666 | 000 |
| 00855306003268 | K070666 | 000 |
| 00855306003251 | K070666 | 000 |
| 00855306003244 | K070666 | 000 |
| 00855306003107 | K070666 | 000 |
| 00855306003091 | K070666 | 000 |