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510(k) K082582

SENTINEL, MODEL SP-001 by C-Rad Positioning AB — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2009
Date Received
September 8, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by C-Rad Positioning AB

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  • K113276 — CATALYST (February 27, 2012)
  • K063839 — POSITIONER (February 8, 2007)

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