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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Tremor
510(k) Number K140086
Device Name PERSONAL KINETIGRAPH (PKG) SYSTEM
Applicant
GKC MANUFACTURING PTY LTD.
1801 ROCKVILLE PIKE
SUITE 300
ROCKVILLE,  MD  20852
Applicant Contact MARIE SCHROEDER
Correspondent
GKC MANUFACTURING PTY LTD.
1801 ROCKVILLE PIKE
SUITE 300
ROCKVILLE,  MD  20852
Correspondent Contact MARIE SCHROEDER
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Codes
ISD   NXQ  
Date Received01/14/2014
Decision Date 08/22/2014
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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