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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 K093125
Device Name ALPHAXENON LIGHT 180 W AND 300 W
Applicant
GIMMI GMBH
CARL-ZEISS-STRASSE 6
TUTTLINGEN,  DE D-78532
Applicant Contact ULRICH HENZLER
Correspondent
GIMMI GMBH
CARL-ZEISS-STRASSE 6
TUTTLINGEN,  DE D-78532
Correspondent Contact ULRICH HENZLER
Regulation Number876.1500
Classification Product Code
GCT  
Date Received10/02/2009
Decision Date 01/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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