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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 K211887
Device Name Personal Kinetigraph (PKG) System Gen 2 Plus
Applicant
Gkc Manufacturing Pty, Ltd.
Level 9, 31 Queen St.
Melbourne,  AU 3000
Applicant Contact Jim Quackenbush
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Kathy Herzog
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Codes
ISD   NXQ  
Date Received06/21/2021
Decision Date 03/11/2022
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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