FDA 510(k) Application Details - K011617

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K011617
Device Name Camera, Multi Format, Radiological
Applicant FERRANIA S.P.A. STABILIMENTO DI FERRANIA
57 VIALE DELLA LIBERTA
FERRANIA, SAVONA 17014 IT
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Contact RICCARDO GENTA
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 05/25/2001
Decision Date 06/08/2001
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 Y
Expedited Review

FDA Source Information for K011617


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