FDA 510(k) Application Details - K030162

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K030162
Device Name Source, Brachytherapy, Radionuclide
Applicant ISORAY, INC
350 HILLS ST.
SUITE 106
RICHLAND, WA 99352 US
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Contact DAVID SWANBERG
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 01/16/2003
Decision Date 03/28/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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