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510(k) K964910

AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS by Alpha-Omega Services, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1997
Date Received
December 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

Other clearances by Alpha-Omega Services, Inc.

  • K233628 — AOS Interstitial Templates, Needles, and Accessories (July 10, 2024)
  • K233626 — AOS Marker Seeds (SMG0242-025) (July 2, 2024)
  • K102811 — AOS ORION IR-192 SOURCE CABLE (June 2, 2011)
  • K062824 — AOS UNIVERSAL CONECTING GUIDE TUBE (July 3, 2007)
  • K062823 — AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES (May 29, 2007)
  • K062826 — AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS (May 22, 2007)
  • K062825 — AOS MARKER SEEDS (May 22, 2007)
  • K991571 — 10 CURIE IRDIUM 192, CSN00100-192 (February 22, 2000)

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