FDA 510(k) Application Details - K033770

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K033770
Device Name Source, Brachytherapy, Radionuclide
Applicant ISOAID, L.L.C.
7824 CLARK MOODY BLVD.
PORT RICHEY, FL 34668 US
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Contact MAX TAGHIZADEH
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 12/03/2003
Decision Date 04/08/2004
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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