FDA 510(k) Application Details - K012492

Device Classification Name Dynamometer, Ac-Powered

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510(K) Number K012492
Device Name Dynamometer, Ac-Powered
Applicant KADA RESEARCH, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071-3404 US
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Contact HARVEY KNAUSS
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Regulation Number 888.1240

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Classification Product Code LBB
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Date Received 08/03/2001
Decision Date 11/02/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K012492


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