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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleep Appliances With Patient Monitoring
510(k) Number K160239
Device Name TAP 3, TAP 1
Applicant
Airway Management, Inc.
3418 Midcourt Rd., Suite 114
Carrollton,  TX  75006
Applicant Contact Dale Siebenmorgen
Correspondent
Promedic, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
PLC  
Subsequent Product Code
LRK  
Date Received02/01/2016
Decision Date 08/10/2016
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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