FDA 510(k) Application Details - K060636

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K060636
Device Name Source, Brachytherapy, Radionuclide
Applicant C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON, GA 30014-6421 US
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Contact JULIE J BASSETT
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 03/10/2006
Decision Date 04/19/2006
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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