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510(k) K060749

XPERCT by Philips Medical Systems North America Co. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2006
Date Received
March 20, 2006
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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