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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lamp, infrared, therapeutic heating
510(k) Number K051680
Device Name DYNATRON DX2 TRACTION UNIT
Applicant
DYNATRONICS CORP.
7030 PARK CENTRE DR.
salt lake city,  UT  84121
Applicant Contact ron hatch
Correspondent
DYNATRONICS CORP.
7030 PARK CENTRE DR.
salt lake city,  UT  84121
Correspondent Contact ron hatch
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Code
ITH  
Date Received06/23/2005
Decision Date 10/11/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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