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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 K220330
Device Name Soundly Anti Snoring Device
Applicant
Greystone Ip, Ltd.
Unit 322, Moat House, 54 Bloomfield Ave.
Belfast,  IE BT5 5AD
Applicant Contact Judy Purvis
Correspondent
Greystone Ip, Ltd.
Unit 322, Moat House, 54 Bloomfield Ave.
Belfast,  IE BT5 5AD
Correspondent Contact Judy Purvis
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/04/2022
Decision Date 09/08/2022
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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