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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
510(k) Number K944935
Device Name DYNATRON 250
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 Number890.5850
Classification Product Code
IPF  
Date Received10/06/1994
Decision Date 06/22/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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