The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Auto-vac (tm) Autotransfusion Reserv, Model 7900.
| Device ID | K862684 |
| 510k Number | K862684 |
| Device Name: | AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900 |
| Classification | Apparatus, Autotransfusion |
| Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Contact | John R Boehringer |
| Correspondent | John R Boehringer 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 | 1986-07-15 |
| Decision Date | 1986-10-17 |