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FDA 510(k) Application Details - K021717
Device Classification Name
Light Source, Endoscope, Xenon Arc
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510(K) Number
K021717
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
05/23/2002
Decision Date
08/20/2002
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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