FDA 510(k) Application Details - K062736

Device Classification Name

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510(K) Number K062736
Device Name SIASCOPE V
Applicant ASTRON CLINICA LIMITED
1676 VILLAGE GREEN
SUITE A
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number

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Classification Product Code PSN
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Date Received 09/13/2006
Decision Date 09/14/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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