The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Baby E.t. Tape Ii.
Device ID | K900912 |
510k Number | K900912 |
Device Name: | BABY E.T. TAPE II |
Classification | Device, Fixation, Tracheal Tube |
Applicant | B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
Contact | Briggs Iii |
Correspondent | Briggs Iii B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
Product Code | CBH |
CFR Regulation Number | 868.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-27 |
Decision Date | 1990-08-03 |