The following data is part of a premarket notification filed by Baxter Bentley Laboratories, Inc. with the FDA for Membrane Oxygenator.
| Device ID | K882892 |
| 510k Number | K882892 |
| Device Name: | MEMBRANE OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | BAXTER BENTLEY LABORATORIES, INC. P.O. BOX 19522 Irvine, CA 92713 |
| Contact | Merritt Girgis |
| Correspondent | Merritt Girgis BAXTER BENTLEY LABORATORIES, INC. 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 | 1988-07-11 |
| Decision Date | 1988-09-27 |