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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K010565
Device Name DYNATRON STS
Applicant
DYNATRONICS CORP.
7030 PARK CENTRE DR.
SALT LAKE CITY,  UT  84121
Applicant Contact JOHN S RAMEY
Correspondent
DYNATRONICS CORP.
7030 PARK CENTRE DR.
SALT LAKE CITY,  UT  84121
Correspondent Contact JOHN S RAMEY
Regulation Number882.5890
Classification Product Code
LIH  
Date Received02/26/2001
Decision Date 05/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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