The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Oxygenators #bos-10, 105, 5s.
Device ID | K823456 |
510k Number | K823456 |
Device Name: | OXYGENATORS #BOS-10, 105, 5S |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | BENTLEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-18 |
Decision Date | 1982-12-30 |