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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name locator, acupuncture point
510(k) Number K792501
Device Name PLS MINI
Original Applicant
STAODYNAMICS, INC.
Regulation Number880.5580
Classification Product Code
BWJ  
Date Received12/04/1979
Decision Date 02/26/1980
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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