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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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More FDA Info for this Product Code
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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