FDA 510(k) Application Details - K973115

Device Classification Name Illuminator, Radiographic-Film

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510(K) Number K973115
Device Name Illuminator, Radiographic-Film
Applicant ARNOLD & RICHTER CINE TECHNIK
TURKENSTRASSE 89
MUNICH 80799 DE
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Contact THOMAS POPP
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Regulation Number 892.1890

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Classification Product Code IXC
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Date Received 08/20/1997
Decision Date 09/02/1997
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



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