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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 K950348
Device Name DYNATRON 650
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  
Subsequent Product Codes
GZJ   IPF  
Date Received01/27/1995
Decision Date 09/13/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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