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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 K214096
Device Name Respire Clear
Applicant
Respire Medical, LLC
18 Bridge St.
Brooklyn,  NY  11201
Applicant Contact David Walton
Correspondent
Respire Medical, LLC
18 Bridge St.
Brooklyn,  NY  11201
Correspondent Contact David Walton
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received12/28/2021
Decision Date 05/31/2022
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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