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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 K834487
Device Name FLEXIBLE LIQUID LIGHT GUIDE
Applicant
ENDO LASE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ENDO LASE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
FFS  
Date Received12/13/1983
Decision Date 02/21/1984
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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