The following data is part of a premarket notification filed by American Bentley with the FDA for Adjustable Oxygenator Holder Model No. Bcm-hl.
| Device ID | K860672 |
| 510k Number | K860672 |
| Device Name: | ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-24 |
| Decision Date | 1986-03-03 |