FDA 510(k) Application Details - K991571

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K991571
Device Name Source, Brachytherapy, Radionuclide
Applicant ALPHA-OMEGA SERVICES, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071 US
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Contact J. HARVEY KNAUSS
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 05/05/1999
Decision Date 02/22/2000
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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