FDA 510(k) Application Details - K020683

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K020683
Device Name Source, Brachytherapy, Radionuclide
Applicant ATI MEDICAL, INC.
10954-A VIA FRONTERA
SAN DIEGO, CA 92127 US
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Contact MICHAEL WIENHOLT
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 03/04/2002
Decision Date 12/17/2002
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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