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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Isokinetic Testing And Evaluation
510(k) Number K862994
Device Name PORTABLE ISOKINETICS 3002 ISO KANE II
Applicant
KENT DESIGN & MANUFACTURING, INC.
3522 LOUSMA DR., SE
GRAND RAPIDS,  MI  49548
Applicant Contact ANDREW J VANNOORD
Correspondent
KENT DESIGN & MANUFACTURING, INC.
3522 LOUSMA DR., SE
GRAND RAPIDS,  MI  49548
Correspondent Contact ANDREW J VANNOORD
Regulation Number890.1925
Classification Product Code
IKK  
Date Received08/08/1986
Decision Date 08/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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