FDA 510(k) Application Details - K060679

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K060679
Device Name Source, Brachytherapy, Radionuclide
Applicant NORTH AMERICAN SCIENTIFIC, INC.
20200 SUNBURST ST.
CHATSWORTH, CA 91311 US
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Contact LEIGH SPOTTEN
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 03/15/2006
Decision Date 04/21/2006
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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