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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamometer, Ac-Powered
510(k) Number K860226
Device Name FORCE EVALUATION AND TESTING SYSTEM (FETS)
Applicant
Hoggan Health Industries, Inc.
111 E. 12300 S.
P.O. Box 957
Draper,  UT  84020
Applicant Contact ROBERT SMITH
Correspondent
Hoggan Health Industries, Inc.
111 E. 12300 S.
P.O. Box 957
Draper,  UT  84020
Correspondent Contact ROBERT SMITH
Regulation Number888.1240
Classification Product Code
LBB  
Date Received01/22/1986
Decision Date 03/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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