The following data is part of a premarket notification filed by Tempe Biomedical, Inc. with the FDA for Trach Mate.
Device ID | K834265 |
510k Number | K834265 |
Device Name: | TRACH MATE |
Classification | Support, Breathing Tube |
Applicant | TEMPE BIOMEDICAL, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | JAY |
CFR Regulation Number | 868.5280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-08 |
Decision Date | 1984-01-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRACH MATE 73760072 1546280 Dead/Cancelled |
MCCORMICK LABORATORIES, INC. 1988-10-27 |