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510(k) K033184

LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 by Shimadzu Corp. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2003
Date Received
October 1, 2003
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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