The following data is part of a premarket notification filed by Equilibrated Bio Systems, Inc. with the FDA for Adult Zee-frame.
Device ID | K790410 |
510k Number | K790410 |
Device Name: | ADULT ZEE-FRAME |
Classification | Support, Breathing Tube |
Applicant | EQUILIBRATED BIO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JAY |
CFR Regulation Number | 868.5280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-26 |
Decision Date | 1979-03-22 |