FDA 510(k) Application Details - K030066

Device Classification Name Calibrator, Dose, Radionuclide

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510(K) Number K030066
Device Name Calibrator, Dose, Radionuclide
Applicant NUCLEAR ASSOCIATES
120 ANDREWS RD.
HICKSVILLE, NY 11801 US
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Contact CHRISTINE G CASTLEBERRY
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Regulation Number 892.1360

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Classification Product Code KPT
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Date Received 01/07/2003
Decision Date 08/29/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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