FDA 510(k) Application Details - K030110

Device Classification Name System, Applicator, Radionuclide, Remote-Controlled

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510(K) Number K030110
Device Name System, Applicator, Radionuclide, Remote-Controlled
Applicant MICK RADIO-NUCLEAR INSTRUMENTS, INC.
521 HOMESTEAD AVE.
MOUNT VERNON, NY 10550 US
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Contact FELIX MICK
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Regulation Number 892.5700

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Classification Product Code JAQ
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Date Received 01/13/2003
Decision Date 04/03/2003
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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