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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ultrasonic diathermy for use in applying therapeutic deep heat
510(k) Number K120171
Model AA 170
Device Name ACCUSONIC ADVANTAGE
Original Applicant
METRON MEDICAL AUSTRALIA PTY LTD
57 aster ave.
carrum downs,  AS 3201
Original Contact david mitchell
Regulation Number890.5300
Classification Product Code
IMI  
Date Received01/20/2012
Decision Date 05/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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