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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image, Illumination, Fiberoptic, For Endoscope
510(k) Number K940963
Device Name XENON LIGHT SOURCE
Applicant
INCREDIVISION, INC.
24 DENTON RD.
WELLESLEY,  MA  02181 -6405
Applicant Contact THOMAS P KLEIN
Correspondent
INCREDIVISION, INC.
24 DENTON RD.
WELLESLEY,  MA  02181 -6405
Correspondent Contact THOMAS P KLEIN
Regulation Number876.1500
Classification Product Code
FFS  
Date Received03/02/1994
Decision Date 04/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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