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FDA 510(k) Application Details - K971407
Device Classification Name
Dynamometer, Nonpowered
More FDA Info for this Device
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
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
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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