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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K181482
Device Name myTAP2
Applicant
Airway Management, Inc.
3418 Midcourt Rd.
Carrollton,  TX  75006
Applicant Contact Eric Jarrett
Correspondent
Airway Management, Inc.
3418 Midcourt Rd.
Carrollton,  TX  75006
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/05/2018
Decision Date 08/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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