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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
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