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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light source, endoscope, xenon arc
510(k) Number K023468
Device Name ENDOSCOPIC LIGHT SOURCE XL180/L3
Applicant
WORLD OF MEDICINE LEMKE GMBH
91 TROWBRIDGE ST.
CAMBRIDGE,  MA  02138
Applicant Contact SUSANNE RAAB
Correspondent
WORLD OF MEDICINE LEMKE GMBH
91 TROWBRIDGE ST.
CAMBRIDGE,  MA  02138
Correspondent Contact SUSANNE RAAB
Regulation Number876.1500
Classification Product Code
GCT  
Date Received10/16/2002
Decision Date 01/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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