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FDA 510(k) Application Details - K102013
Device Classification Name
Camera, Ophthalmic, Ac-Powered
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510(K) Number
K102013
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
CANON, INC.-MEDICAL EQUIPMENT GROUP
3F 2-17-6 AKEBONO-CHO
TACHIKAWA-SHI, TOKYO 190-0012 JP
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Contact
KOJI KUBO
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
07/16/2010
Decision Date
10/29/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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