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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K163448
Device Name GrindCare System
Applicant
Sunstar Suisse S.A.
Route De Pallatex 11
Etoy,  CH 1163
Applicant Contact Olivier Ducamp
Correspondent
Biologics Consulting
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Calley Herzog
Regulation Number882.5050
Classification Product Code
HCC  
Subsequent Product Codes
KZM   NUW  
Date Received12/08/2016
Decision Date 09/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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