FDA 510(k) Application Details - K030878

Device Classification Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat

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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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Contact DAVE TOMAN
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Regulation Number 890.5300

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Classification Product Code IMI
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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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