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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Dental Sonography, For Monitoring Jaw Sounds
510(k) Number K970116
Device Name ESG-1 ELECTROSONOGRAM (ESG-1)
Applicant
Myo-Tronics, Inc.
15425 - 33rd Ave. S.
Tukwila,  WA  98188
Applicant Contact FRAY ADIB
Correspondent
Myo-Tronics, Inc.
15425 - 33rd Ave. S.
Tukwila,  WA  98188
Correspondent Contact FRAY ADIB
Regulation Number872.2050
Classification Product Code
NFQ  
Subsequent Product Code
NFS  
Date Received01/13/1997
Decision Date 04/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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