The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Block, Bite, Intubation.
Device ID | K873491 |
510k Number | K873491 |
Device Name: | BLOCK, BITE, INTUBATION |
Classification | Support, Breathing Tube |
Applicant | B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
Contact | Stephen W Briggs |
Correspondent | Stephen W Briggs B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
Product Code | JAY |
CFR Regulation Number | 868.5280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-31 |
Decision Date | 1987-10-20 |