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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, Dental
510(k) Number K842224
Device Name BNS 40
Applicant
Myo-Tronics Research, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact FRAY ADIB
Correspondent
Myo-Tronics Research, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact FRAY ADIB
Regulation Number890.5850
Classification Product Code
NUW  
Date Received06/05/1984
Decision Date 11/19/1984
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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