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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 K061732
Device Name TAP-T
Applicant
Airway Management, Inc.
6116 N. Central Expy.
Suite 605
Dallas,  TX  75206
Applicant Contact DARREN HENDERSON
Correspondent
Airway Management, Inc.
6116 N. Central Expy.
Suite 605
Dallas,  TX  75206
Correspondent Contact DARREN HENDERSON
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/20/2006
Decision Date 07/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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