ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5


Device Classification Name

light source, endoscope, xenon arc

510(k) Number K021717
Device Name ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
Original Applicant
WORLD OF MEDICINE LEMKE GMBH
91 trowbridge st.
cambridge, 
MA 
02138

Original Contact susanne raab
Regulation Number 876.1500
Classification Product Code
GCT  
Date Received 05/23/2002
Decision Date 08/20/2002
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