FDA 510(k) Application Details - K132969

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K132969
Device Name Source, Brachytherapy, Radionuclide
Applicant SOURCE PRODUCTION & EQUIPMENT CO., INC.
113 Teal St.
Saint Rose, LA 70087 US
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Contact KELLEY RICHARDT
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 09/23/2013
Decision Date 01/02/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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