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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 K124010
Device Name ACCUSONIC ADVANTAGE
Applicant
Metron Medical Australia, Pty, Ltd.
57 Aster Ave.
Carrum Downs,  AU 3201
Applicant Contact DAVID MITCHELL
Correspondent
Metron Medical Australia, Pty, Ltd.
57 Aster Ave.
Carrum Downs,  AU 3201
Correspondent Contact DAVID MITCHELL
Regulation Number890.5300
Classification Product Code
IMI  
Date Received12/27/2012
Decision Date 08/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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