The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Arterial Blood Filter, Model Af-10.
Device ID | K792450 |
510k Number | K792450 |
Device Name: | ARTERIAL BLOOD FILTER, MODEL AF-10 |
Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
Applicant | BENTLEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DTM |
CFR Regulation Number | 870.4260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-03 |
Decision Date | 1979-12-19 |