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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamometer, Nonpowered
510(k) Number K971407
Device Name JTECH COMMANDER AND ALGOMETER
Applicant
J-TECH MEDICAL, INC.
357 WEST 910 SOUTH
HEBER CITY,  UT  84032
Applicant Contact E. J SMITH
Correspondent
J-TECH MEDICAL, INC.
357 WEST 910 SOUTH
HEBER CITY,  UT  84032
Correspondent Contact E. J SMITH
Regulation Number888.1250
Classification Product Code
HRW  
Date Received04/16/1997
Decision Date 04/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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