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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 K162412
Device Name Hoggan Scientific® microFET2™
Applicant
Hoggan Scientific, LLC
3653 West 1987 South Bld. # 7
Salt Lake City,  UT  84104
Applicant Contact Spencer Walker
Correspondent
Hoggan Scientific, LLC
3653 West 1987 South Bld. # 7
Salt Lake City,  UT  84104
Correspondent Contact Spencer Walker
Regulation Number888.1240
Classification Product Code
LBB  
Date Received08/29/2016
Decision Date 03/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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