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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
Airway Management, Inc.
3418 Midcourt Road, Ste. 114
Carrollton,  TX  75006
Applicant Contact Dale Siebenmorgen
ProMedic, Inc.
24301 Woodsage Drive
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
Subsequent Product Code
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