The following data is part of a premarket notification filed by American Bentley with the FDA for Blood Oxygenator Heat Exhanger Coating.
| Device ID | K833518 |
| 510k Number | K833518 |
| Device Name: | BLOOD OXYGENATOR HEAT EXHANGER COATING |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 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 | 1983-10-11 |
| Decision Date | 1983-12-29 |