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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K133752
Device Name SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
Applicant
Sonendo, Inc.
26061 Merit Circle, Suite 101
Laguna Hills,  CA  92653
Applicant Contact DAN MILLER
Correspondent
Sonendo, Inc.
26061 Merit Circle, Suite 101
Laguna Hills,  CA  92653
Correspondent Contact DAN MILLER
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/09/2013
Decision Date 05/15/2014
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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