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510(k) K063378

CIRRUS HD-OCT, MODEL 4000 by Carl Zeiss Meditec, Inc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2007
Date Received
November 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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