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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 K210636
Device Name Morpheus
Applicant
S4S UK Ltd.
151 Rutland Road
Sheffield,  GB S3 9PT
Applicant Contact Matthew Everatt
Correspondent
S4S UK Ltd.
151 Rutland Road
Sheffield,  GB S3 9PT
Correspondent Contact Matthew Everatt
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/19/2021
Decision Date 02/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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