The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Autotransfusion Device.
Device ID | K892819 |
510k Number | K892819 |
Device Name: | AUTOTRANSFUSION DEVICE |
Classification | Apparatus, Autotransfusion |
Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
Contact | Philip Goforth |
Correspondent | Philip Goforth 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 | 1989-04-17 |
Decision Date | 1989-05-22 |