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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
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
Applicant Contact MICHAEL A DANIEL
Correspondent
FLUOPTICS
8 SNOWBERRY COURT
ORINDA,  CA  94563
Correspondent Contact MICHAEL A DANIEL
Regulation Number876.1500
Classification Product Code
OWN  
Date Received08/07/2013
Decision Date 05/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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