The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Blood Cardioplegia Heat Exchanger, Model #he-30.
Device ID | K913956 |
510k Number | K913956 |
Device Name: | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
Contact | Jill Schweiger |
Correspondent | Jill Schweiger BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-05 |
Decision Date | 1992-01-17 |