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510(k) K102811

AOS ORION IR-192 SOURCE CABLE by Alpha-Omega Services, Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2011
Date Received
September 28, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Alpha-Omega Services, Inc.

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  • K062824 — AOS UNIVERSAL CONECTING GUIDE TUBE (July 3, 2007)
  • K062823 — AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES (May 29, 2007)
  • K062825 — AOS MARKER SEEDS (May 22, 2007)
  • K062826 — AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS (May 22, 2007)
  • K991571 — 10 CURIE IRDIUM 192, CSN00100-192 (February 22, 2000)
  • K964910 — AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS (March 10, 1997)

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