FDA 510(k) Application Details - K123014

Device Classification Name

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510(K) Number K123014
Device Name LITECURE THERAPY SYSTEM MODEL LTS-1500
Applicant LITECURE, LLC
250 Corporate Blvd.
Suite B
NEWARK, DE 19702 US
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Contact LIANG LU
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Regulation Number

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Classification Product Code PDZ
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Date Received 09/27/2012
Decision Date 03/29/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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