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 |