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FDA 510(k) Applications Submitted by Tsutomu Sunada
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221320
05/06/2022
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
Nidek Co., LTD.
K192045
07/31/2019
Ophthalmic Yag Laser System YC-200
Nidek Co., Ltd.
K203130
10/19/2020
Ophthalmic Yag Laser System YC-200
Nidek Co., Ltd.
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