The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Hibernation Kit.
Device ID | K892660 |
510k Number | K892660 |
Device Name: | HIBERNATION KIT |
Classification | Anesthesia Conduction Kit |
Applicant | DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
Contact | Robert T Horan |
Correspondent | Robert T Horan DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-13 |
Decision Date | 1989-08-15 |