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FDA 510(k) Application Details - K124010
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K124010
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
METRON MEDICAL AUSTRALIA PTY LTD
57 ASTER AVE.
CARRUM DOWNS, VICTORIA 3201 AU
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Contact
DAVID MITCHELL
Other 510(k) Applications for this Contact
Regulation Number
890.5300
More FDA Info for this Regulation Number
Classification Product Code
IMI
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More FDA Info for this Product Code
Date Received
12/27/2012
Decision Date
08/23/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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