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FDA 510(k) Application Details - K191945
Device Classification Name
Camera, Ophthalmic, Ac-Powered
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510(K) Number
K191945
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
Kowa Company, Ltd.
3-1, Chofugaoka 3-Chome
Chofu 1820021 JP
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Contact
Nariaki Morita
Other 510(k) Applications for this Contact
Regulation Number
886.1120
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Classification Product Code
HKI
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More FDA Info for this Product Code
Date Received
07/22/2019
Decision Date
09/10/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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