The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Impraflo Autotransfusion Device.
| Device ID | K901232 |
| 510k Number | K901232 |
| Device Name: | IMPRAFLO AUTOTRANSFUSION DEVICE |
| Classification | Apparatus, Autotransfusion |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | Janine E Rhodes |
| Correspondent | Janine E Rhodes 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 | 1990-03-14 |
| Decision Date | 1990-07-18 |