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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, muscle monitoring
510(K) Number K113677
Device Name GRINDCARE MEASURE
Applicant
MEDOTECH A/S
13417 quivas st
westminster,  CO  80234
Contact calley herzog
Regulation Number890.1375
Classification Product Code
KZM  
Date Received12/14/2011
Decision Date 04/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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