The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Adhesive E.t. Tape.
Device ID | K925386 |
510k Number | K925386 |
Device Name: | ADHESIVE E.T. TAPE |
Classification | Device, Fixation, Tracheal 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 | CBH |
CFR Regulation Number | 868.5770 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-26 |
Decision Date | 1993-04-19 |