The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Univox W/holders, Models Univox-hl, Hlb, Hlf.
| Device ID | K894826 |
| 510k Number | K894826 |
| Device Name: | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible BENTLEY LABORATORIES, INC. P.O. BIX 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 | 1989-07-31 |
| Decision Date | 1990-02-28 |