The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Cardioplegia Administration System Cas.
Device ID | K800135 |
510k Number | K800135 |
Device Name: | CARDIOPLEGIA ADMINISTRATION SYSTEM CAS |
Classification | Filter, Prebypass, Cardiopulmonary Bypass |
Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRJ |
CFR Regulation Number | 870.4280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-21 |
Decision Date | 1980-02-01 |