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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 K190051
Device Name TD Clip
Applicant
Zephyr Sleep Technologies, Inc.
102, 701 64 Ave. SE
Calgary,  CA T2H 2C3
Applicant Contact Sabina Bruehlmann
Correspondent
Zephyr Sleep Technologies, Inc.
102, 701 64 Ave. SE
Calgary,  CA T2H 2C3
Correspondent Contact Sabina Bruehlmann
Regulation Number872.5570
Classification Product Code
LRK  
Date Received01/11/2019
Decision Date 06/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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