FDA 510(k) Application Details - K953165

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K953165
Device Name Camera, Multi Format, Radiological
Applicant INTERNATIONAL IMAGING ELECTRONICS
881 REMINGTON BLVD.
BOLINGBROOK, IL 60440-4932 US
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Contact ROGER CLAAR
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 07/07/1995
Decision Date 05/07/1996
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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