The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for E. T. Tape Endotracheal Tube Holder.
Device ID | K862084 |
510k Number | K862084 |
Device Name: | E. T. TAPE ENDOTRACHEAL TUBE HOLDER |
Classification | Device, Fixation, Tracheal Tube |
Applicant | B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
Contact | Briggs, Iii |
Correspondent | Briggs, Iii B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
Product Code | CBH |
CFR Regulation Number | 868.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-02 |
Decision Date | 1986-06-05 |