FDA 510(k) Application Details - K002446

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K002446
Device Name Source, Brachytherapy, Radionuclide
Applicant SUN NUCLEAR CORP.
425-A PINEDA COURT
MELBOURNE, FL 32940 US
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Contact THOMAS L POWERS
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 08/09/2000
Decision Date 10/23/2000
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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