FDA 510(k) Application Details - K971407

Device Classification Name Dynamometer, Nonpowered

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510(K) Number K971407
Device Name Dynamometer, Nonpowered
Applicant J-TECH MEDICAL, INC.
357 WEST 910 SOUTH
HEBER CITY, UT 84032 US
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Contact E. J SMITH
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Regulation Number 888.1250

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Classification Product Code HRW
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Date Received 04/16/1997
Decision Date 04/20/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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