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FDA 510(k) Application Details - K955442
Device Classification Name
Camera, Ophthalmic, Ac-Powered
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510(K) Number
K955442
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
KOWA OPTIMED, INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
WASHINGTON, DC 20005 US
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Contact
SAMIA N RODRIGUEZ
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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
11/28/1995
Decision Date
01/03/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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