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FDA 510(k) Application Details - K090326
Device Classification Name
Camera, Ophthalmic, Ac-Powered
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510(K) Number
K090326
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
CLARITY MEDICAL SYSTEMS
5775 WEST LAS POSITAS BLVD.
SUITE 200
PLEASANTON, CA 94588-4084 US
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Contact
GARY A SEEGER
Other 510(k) Applications for this Contact
Regulation Number
886.1120
More FDA Info for this Regulation Number
Classification Product Code
HKI
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More FDA Info for this Product Code
Date Received
02/09/2009
Decision Date
11/25/2009
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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