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510(k) K141136

LEICA FL800 by Leica Biosystems Richmond — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2014
Date Received
May 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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