FDA 510(k) Application Details - K110480

Device Classification Name	More FDA Info for this Device
510(K) Number	K110480
Device Name	PDE PHOTODYNAMIC EYE
Applicant	HAMAMATSU PHOTONICS, K.K. 700 13TH STREET, NW SUITE 1200 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	JEFFREY K SHAPIRO 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	02/18/2011
Decision Date	01/13/2012
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