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510(k) K040804

.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR by Southeastern Radiation Products, Inc. — Product Code IXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2004
Date Received
March 29, 2004
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

Other clearances by Southeastern Radiation Products, Inc.

  • K023636 — BLOCKING TRAY (November 22, 2002)

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  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)
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