The following data is part of a premarket notification filed by Airway Management, Inc. with the FDA for Mytap2.
Device ID | K181482 |
510k Number | K181482 |
Device Name: | MyTAP2 |
Classification | Device, Anti-snoring |
Applicant | Airway Management, Inc. 3418 Midcourt Road Carrollton, TX 75006 |
Contact | Eric Jarrett |
Correspondent | Paul Dryden Airway Management, Inc. 3418 Midcourt Road Carrollton, TX 75006 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-05 |
Decision Date | 2018-08-31 |
Summary: | summary |