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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 K110480
Device Name PDE PHOTODYNAMIC EYE
Applicant
Hamamatsu Photonics K.K.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Applicant Contact JEFFREY K SHAPIRO
Correspondent
Hamamatsu Photonics K.K.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Correspondent Contact JEFFREY K SHAPIRO
Regulation Number876.1500
Classification Product Code
OWN  
Date Received02/18/2011
Decision Date 01/13/2012
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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