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FDA 510(k) Application Details - K023468
Device Classification Name
Light Source, Endoscope, Xenon Arc
More FDA Info for this Device
510(K) Number
K023468
Device Name
Light Source, Endoscope, Xenon Arc
Applicant
WORLD OF MEDICINE LEMKE GMBH
91 TROWBRIDGE ST.
CAMBRIDGE, MA 02138 US
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Contact
SUSANNE RAAB
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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
10/16/2002
Decision Date
01/14/2003
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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