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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 K893440
Device Name FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact JOHN WATKINS
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact JOHN WATKINS
Regulation Number876.1500
Classification Product Code
FFS  
Date Received05/03/1989
Decision Date 07/28/1989
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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