The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Oxygenator, Blood Bos-10.
| Device ID | K781842 |
| 510k Number | K781842 |
| Device Name: | OXYGENATOR, BLOOD BOS-10 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-27 |
| Decision Date | 1978-11-08 |