The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Trach T With One-way Valves.
Device ID | K790888 |
510k Number | K790888 |
Device Name: | TRACH T WITH ONE-WAY VALVES |
Classification | Connector, Airway (extension) |
Applicant | AIRLIFE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-07 |
Decision Date | 1979-06-27 |