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510(k) K052383

INNOCURE IMRT FILTER (COMPENSATORS) by Innocure, LLC — Product Code IXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2006
Date Received
August 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type

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