The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Arterial Blood Filter, Model Af-10.
| Device ID | K792450 |
| 510k Number | K792450 |
| Device Name: | ARTERIAL BLOOD FILTER, MODEL AF-10 |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | BENTLEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-03 |
| Decision Date | 1979-12-19 |