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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamometer, Ac-Powered
510(k) Number K012492
Device Name KADANCE 2000
Applicant
Kada Research, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Applicant Contact HARVEY KNAUSS
Correspondent
Kada Research, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Correspondent Contact HARVEY KNAUSS
Regulation Number888.1240
Classification Product Code
LBB  
Date Received08/03/2001
Decision Date 11/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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