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FDA 510(k) Application Details - K132475
Device Classification Name
More FDA Info for this Device
510(K) Number
K132475
Device Name
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
Applicant
FLUOPTICS
8 SNOWBERRY COURT
ORINDA, CA 94563 US
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Contact
MICHAEL A DANIEL
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/07/2013
Decision Date
05/07/2014
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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