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510(k) K062214

BRACHYSCIENCES STRANDPORT by Worldwide Medical Technologies, LLC — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2007
Date Received
August 1, 2006
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

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  • K981889 — WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE (July 31, 1998)
  • K982097 — WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD (June 25, 1998)
  • K981470 — WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE (June 19, 1998)

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