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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 K811312
Device Name MYO-METRIC II
Applicant
MYCRON MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MYCRON MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.1240
Classification Product Code
LBB  
Date Received05/11/1981
Decision Date 06/09/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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