The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Venous Reservoir Bag Model No. Bmr-250(tm).
| Device ID | K913692 |
| 510k Number | K913692 |
| Device Name: | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
| Contact | Jill Schweiger |
| Correspondent | Jill Schweiger BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1991-11-15 |