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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K880912
Device Name DYNATRON 2000
Applicant
Dynatronics Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Applicant Contact STEVEN R WOODHEAD
Correspondent
Dynatronics Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Correspondent Contact STEVEN R WOODHEAD
Regulation Number890.1615
Classification Product Code
IKE  
Date Received03/03/1988
Decision Date 03/15/1988
Decision Substantially Equivalent (SESE)
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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