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FDA 510(k) Applications Submitted by Optomed Oy
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180378
02/12/2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Optomed Oy
K163021
10/31/2016
HAAG-STREIT FUNDUS MODULE 300
OPTOMED OY
K132186
07/15/2013
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
OPTOMED OY
K092056
07/07/2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
OPTOMED OY
K110986
04/08/2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
OPTOMED OY
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