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FDA 510(k) Applications Submitted by Steve Vitale
FDA 510(k) Number
Submission Date
Device Name
Applicant
K210458
02/16/2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Abbott Medical
K183320
11/30/2018
Ilumien Optis, Optis Integrated, Optis Mobile
St. Jude Medical (now Abbott Medical)
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