FDA 510(k) Application Details - K973965

Device Classification Name Illuminator, Radiographic-Film

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510(K) Number K973965
Device Name Illuminator, Radiographic-Film
Applicant SMARTLIGHT, LTD.
47 HATAASIYA ST.
NESHER 36602 IL
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Contact DAN BEN-ZEEV
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Regulation Number 892.1890

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Classification Product Code IXC
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Date Received 10/17/1997
Decision Date 12/12/1997
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 N
Expedited Review



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