FDA 510(k) Application Details - K991881

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K991881
Device Name Source, Brachytherapy, Radionuclide
Applicant SOURCETECH MEDICAL, L.L.C.
295 E. LIES RD.
CAROL STREAM, IL 60188 US
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Contact DAVID T SIERACKI
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 06/02/1999
Decision Date 03/16/2000
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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