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FDA 510(k) Application Details - K133466
Device Classification Name
More FDA Info for this Device
510(K) Number
K133466
Device Name
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
Applicant
MAUNA KEA TECHNOLOGIES
8 SNOWBERRY COURT
ORINDA, CA 94563 US
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Contact
MICHAEL A DANIEL
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Regulation Number
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Classification Product Code
OWN
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More FDA Info for this Product Code
Date Received
11/12/2013
Decision Date
07/25/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
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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