FDA 510(k) Application Details - K143703

Device Classification Name System,X-Ray,Extraoral Source,Digital

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510(K) Number K143703
Device Name System,X-Ray,Extraoral Source,Digital
Applicant NICAL SPA
VIA SOFFREDINI, 43
MILAN 20126 IT
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Contact ROBERTO NICCOLUCCI
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 12/29/2014
Decision Date 03/18/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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