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FDA 510(k) Applications Submitted by Christine Chun
FDA 510(k) Number
Submission Date
Device Name
Applicant
K151636
06/17/2015
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
ABBOTT MEDICAL OPTICS INC
K192058
08/01/2019
EV1000 Clinical Platform NI, EV1000 Clinical Platform
Edwards Lifesciences, LLC
K182245
08/20/2018
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
Edwards Lifesciences, LLC
K172660
09/05/2017
Duravess bovine pericardial vascular patch
Edwards Lifesciences, LLC
K203131
10/19/2020
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
Edwards Lifesciences, LLC
K190130
01/28/2019
The ClearSight finger cuffs
Edwards Lifesciences, LLC
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