FDA 510(k) Application Details - K970870

Device Classification Name Dynamometer, Nonpowered

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510(K) Number K970870
Device Name Dynamometer, Nonpowered
Applicant NK BIOTECHNICAL CORP.
10850 OLD COUNTY RD. 15
MINNEAPOLIS, MN 55441 US
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Contact KAREN GOTFREDSON
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Regulation Number 888.1250

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Classification Product Code HRW
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Date Received 03/10/1997
Decision Date 05/02/1997
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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