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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Muscle Monitoring
510(k) Number K810528
Device Name MODEL EM-IR
Applicant
Myo-Tronics Research, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Myo-Tronics Research, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.1375
Classification Product Code
KZM  
Date Received02/26/1981
Decision Date 03/31/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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