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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 K791021
Device Name MUSCLE TESTING GUN
Applicant
THE ORTHODYN CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE ORTHODYN CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.1250
Classification Product Code
HRW  
Date Received05/30/1979
Decision Date 06/15/1979
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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