The following data is part of a premarket notification filed by American Bentley with the FDA for Oxygenator Model No. Bentley-10 Plus.
| Device ID | K863249 |
| 510k Number | K863249 |
| Device Name: | OXYGENATOR MODEL NO. BENTLEY-10 PLUS |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-22 |
| Decision Date | 1986-10-20 |