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510(k) K132987

COBRA FUNDUS CAMERA by C.S.O. S.R.L. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2014
Date Received
September 24, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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