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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
KEA Products Ltd
10C, Meyer Ind. Bldg, 2 Chong Yip Street
Kwun Tong,  HK 00000
Applicant Contact Michael Schmidt
Robert T. Bock Consultancy LLC
66 Drovers Lane
Brewster,  NY  10509
Correspondent Contact Robert T. Bock
Regulation Number872.6865
Classification Product Code
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