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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 K884165
Device Name MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS
Applicant
Spark Instruments & Academics, Inc.
P.O. Box 5123
Coralville,  IA  52241
Applicant Contact SMIDT, PHD
Correspondent
Spark Instruments & Academics, Inc.
P.O. Box 5123
Coralville,  IA  52241
Correspondent Contact SMIDT, PHD
Regulation Number888.1240
Classification Product Code
LBB  
Date Received10/04/1988
Decision Date 10/26/1988
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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