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FDA 510(k) Application Details - K970870
Device Classification Name
Dynamometer, Nonpowered
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.1250
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Classification Product Code
HRW
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More FDA Info for this Product Code
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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