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510(k) K190056

KOWA VK-2s by Kowa Co. Ltd. Chofu — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2019
Date Received
January 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

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