The following data is part of a premarket notification filed by Perfusion Partners & Assoc. Inc. with the FDA for Secquire Cell Separator.
| Device ID | K024080 |
| 510k Number | K024080 |
| Device Name: | SECQUIRE CELL SEPARATOR |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | PERFUSION PARTNERS & ASSOC. INC. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith PERFUSION PARTNERS & ASSOC. INC. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-10 |
| Decision Date | 2003-07-02 |