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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 K161717
Device Name Personal Kinetigraph (PKG) System
Applicant
Gkc Manufacturing Pty, Ltd.
Level 15, 440 Collins St.
Melbourne,  AU 3000
Applicant Contact BRENDAN FAFIANI
Correspondent
Quintiles
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Correspondent Contact MARIE A. SCHROEDER
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Codes
ISD   NXQ  
Date Received06/22/2016
Decision Date 09/20/2016
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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