The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Cordiotomy Reservoir.
Device ID | K812008 |
510k Number | K812008 |
Device Name: | CORDIOTOMY RESERVOIR |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-17 |
Decision Date | 1981-07-28 |