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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Tongue Scraper
510(k) Number K181986
Device Name Klinly Ultrasonic Tongue Cleaner
Applicant
Kea Products, Ltd.
10c, Meyer Ind. Bldg, 2 Chong Yip St.
Kwun Tong,  HK 00000
Applicant Contact Michael Schmidt
Correspondent
Robert T. Bock Consultancy, LLC
66 Drovers Ln.
Brewster,  NY  10509
Correspondent Contact Robert T. Bock
Regulation Number872.6865
Classification Product Code
QIA  
Date Received07/25/2018
Decision Date 09/06/2019
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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