The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Venous Reservoir Bag #bmr-1400.
| Device ID | K823272 |
| 510k Number | K823272 |
| Device Name: | VENOUS RESERVOIR BAG #BMR-1400 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-02 |
| Decision Date | 1982-12-30 |