The following data is part of a premarket notification filed by Blake Medical, Inc. with the FDA for Breathing Tube Support.
Device ID | K933420 |
510k Number | K933420 |
Device Name: | BREATHING TUBE SUPPORT |
Classification | Device, Fixation, Tracheal Tube |
Applicant | BLAKE MEDICAL, INC. P.O. BOX 1255 Tifton, GA 31793 |
Contact | Mark B Lott |
Correspondent | Mark B Lott BLAKE MEDICAL, INC. P.O. BOX 1255 Tifton, GA 31793 |
Product Code | CBH |
CFR Regulation Number | 868.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-13 |
Decision Date | 1993-10-13 |