FDA 510(k) Application Details - K961601

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

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510(K) Number K961601
Device Name System, Applicator, Radionuclide, Remote-Controlled
Applicant MICK RADIO-NUCLEAR INSTRUMENTS, INC.
1470 OUTLOOK AVE.
P.O. BOX 99
BRONX, NY 10465 US
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Contact FELIX W MICK
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Regulation Number 892.5700

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Classification Product Code JAQ
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Date Received 04/25/1996
Decision Date 12/23/1996
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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