The following data is part of a premarket notification filed by American Bentley with the FDA for Venous Reservoir-bmr-1500-hard Shell.
| Device ID | K842373 |
| 510k Number | K842373 |
| Device Name: | VENOUS RESERVOIR-BMR-1500-HARD SHELL |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-15 |
| Decision Date | 1984-12-27 |