FDA 510(k) Application Details - K062214

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K062214
Device Name Source, Brachytherapy, Radionuclide
Applicant WORLDWIDE MEDICAL TECHNOLOGIES, LLC
115 HURLEY ROAD BLDG. 3B
OXFORD, CT 06478 US
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Contact WAYNE W RICHARDSON
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 08/01/2006
Decision Date 03/01/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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