The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Autovac (r) Autotransfusion System, 7900 Modified.
| Device ID | K904164 |
| 510k Number | K904164 |
| Device Name: | AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED |
| Classification | Apparatus, Autotransfusion |
| Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Contact | John Karpowicz |
| Correspondent | John Karpowicz BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1991-09-06 |