FDA 510(k) Applications for Medical Device Product Code "HQM"
(Keratoprosthesis, Permanent Implant)

FDA 510(k) Number Applicant Device Name Decision Date
K013756 ARGUS BIOMEDICAL PTY LTD ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) 08/29/2002
K121203 MASSACHUSETTS EYE & EAR INFIRMARY BOSTON KERATOPROSTHESIS OR BOSTON KPRO 05/10/2013
K182986 Massachusetts Eye and Ear Infirmary d/b/a Boston Boston Keratoprosthesis, Type I Lucia 01/30/2019


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