The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Auto-vac Intraoperative Autotrans. Reservoir #7904.
| Device ID | K881129 |
| 510k Number | K881129 |
| Device Name: | AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904 |
| Classification | Apparatus, Autotransfusion |
| Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Contact | Karpowicz, M.e. |
| Correspondent | Karpowicz, M.e. 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 | 1988-03-16 |
| Decision Date | 1988-06-14 |