FDA 510(k) Application Details - K030295

Device Classification Name Light, Lymphedema Reduction, Low Energy

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510(K) Number K030295
Device Name Light, Lymphedema Reduction, Low Energy
Applicant RIANCORP PTY LTD
5818 PRINCESS CAROLINE PLACE
LEESBURG, FL 34748 US
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Contact ROBERT T HANDREN
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Regulation Number 890.5500

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Classification Product Code NZY
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Date Received 01/28/2003
Decision Date 12/23/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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