FDA 510(k) Application Details - K043246

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K043246
Device Name Source, Brachytherapy, Radionuclide
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON, GA 30014 US
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Contact JOHN C KNORPP
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 11/23/2004
Decision Date 02/02/2005
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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