FDA 510(k) Application Details - K963037

Device Classification Name System, Image Processing, Radiological

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510(K) Number K963037
Device Name System, Image Processing, Radiological
Applicant INFIMED, INC.
121 METROPOLITAN DR.
LIVERPOOL, NY 13088 US
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Contact MORTEZA MINAEE
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/05/1996
Decision Date 09/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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