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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 K092675
Device Name GRINDCARE
Applicant
MEDOTECH A/S
13417 QUIVAS ST
WESTMINSTER,  CO  80234
Applicant Contact Calley Herzog
Correspondent
MEDOTECH A/S
13417 QUIVAS ST
WESTMINSTER,  CO  80234
Correspondent Contact Calley Herzog
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/01/2009
Decision Date 03/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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