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FDA 510(k) Application Details - K971057
Device Classification Name
Light Source, Endoscope, Xenon Arc
More FDA Info for this Device
510(K) Number
K971057
Device Name
Light Source, Endoscope, Xenon Arc
Applicant
COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA, CA 91355-1137 US
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Contact
RICHARD B DAVIES
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Regulation Number
876.1500
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Classification Product Code
GCT
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More FDA Info for this Product Code
Date Received
03/24/1997
Decision Date
03/28/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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