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510(k) K100468

ZEISS INFRARED 800 WITH FLOW 800 OPTION by Carl Zeiss Surgical GmbH — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2010
Date Received
February 18, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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