FDA 510(k) Application Details - K162412

Device Classification Name Dynamometer, Ac-Powered

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510(K) Number K162412
Device Name Dynamometer, Ac-Powered
Applicant Hoggan Scientific, LLC
3653 West 1987 South Bld. # 7
Salt Lake City, UT 84104 US
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Contact Spencer Walker
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Regulation Number 888.1240

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Classification Product Code LBB
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Date Received 08/29/2016
Decision Date 03/09/2017
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



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