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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 W. 910 S.
Heber City,  UT  84032
Applicant Contact E. J SMITH
Correspondent
J-Tech Medical, Inc.
357 W. 910 S.
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
Predetermined Change
Control Plan Authorized		 No
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