FDA 510(k) Application Details - K071550

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K071550
Device Name Source, Brachytherapy, Radionuclide
Applicant CP MEDICAL
5203 BRISTOL INDUSTRIAL WAY
BUFORD, GA 30518 US
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Contact BETSY CORTELLONI
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 06/06/2007
Decision Date 07/18/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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