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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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More FDA Info for this Product Code
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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