The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Impraflo(tm) Post Operative/drain/reinfus Kit/cani.
| Device ID | K925827 |
| 510k Number | K925827 |
| Device Name: | IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI |
| Classification | Apparatus, Autotransfusion |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | Joseph J Schwoebel |
| Correspondent | Joseph J Schwoebel IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1993-07-29 |