The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Mast For Basic Heater-cooler Unit 16-09-00.
Device ID | K883332 |
510k Number | K883332 |
Device Name: | MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 |
Classification | Heat-exchanger, Cardiopulmonary Bypass |
Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Contact | Ganz Pobuda |
Correspondent | Ganz Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Product Code | DTR |
CFR Regulation Number | 870.4240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-08 |
Decision Date | 1988-09-26 |