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FDA 510(k) Application Details - K030878
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K030878
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
METRON MEDICAL AUSTRALIA, PTY, LTD.
57 ASTER AVE., P.O. BOX 2164
CARRUM DOWNS, VICTORIA 3201 AU
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DAVE TOMAN
Other 510(k) Applications for this Contact
Regulation Number
890.5300
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Classification Product Code
IMI
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More FDA Info for this Product Code
Date Received
03/20/2003
Decision Date
03/28/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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