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FDA 510(k) Application Details - K001698
Device Classification Name
Image, Illumination, Fiberoptic, For Endoscope
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510(K) Number
K001698
Device Name
Image, Illumination, Fiberoptic, For Endoscope
Applicant
COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA, CA 91355-1137 US
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ED CURRIE
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Regulation Number
876.1500
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Classification Product Code
FFS
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Date Received
06/02/2000
Decision Date
07/17/2000
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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