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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K900639
Device Name DYNATRON 350 EMG/BIOFEEDBACK ANALYZER
Applicant
Dynatronics Laser Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Applicant Contact H CULLIMORE
Correspondent
Dynatronics Laser Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Correspondent Contact H CULLIMORE
Regulation Number882.5050
Classification Product Code
HCC  
Date Received02/09/1990
Decision Date 10/04/1990
Decision Substantially Equivalent (SESE)
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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