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510(k) K080612

LEICA FL800 by Leica Microsystems (Schweiz) AG — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2008
Date Received
March 4, 2008
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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