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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 K252374
Device Name Nylon flexTAP(R)
Applicant
Airway Technologies D/B/A Airway Management
4300 Alpha Rd. #115
Farmers Branch,  TX  75244
Applicant Contact Charles Collins
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
LRK  
Date Received07/30/2025
Decision Date 09/11/2025
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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