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FDA 510(k) Application Details - K023729
Device Classification Name
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510(K) Number
K023729
Device Name
SIASCOPE II
Applicant
ASTRON CLINICA LIMITED
PO BOX 4341
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
11/06/2002
Decision Date
02/03/2003
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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