FDA 510(k) Application Details - K103723

Device Classification Name System, Image Processing, Radiological

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510(K) Number K103723
Device Name System, Image Processing, Radiological
Applicant SICAT GMBH & CO. KG
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact MARK W SHEEHAN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/21/2010
Decision Date 05/20/2011
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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