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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sigmoidoscope and accessories, flexible/rigid
510(k) Number K970382
Device Name VS-100 VIDEO SIGMOIDOSCOPE
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact LAWRENCE E MAROCCO
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact LAWRENCE E MAROCCO
Regulation Number876.1500
Classification Product Code
FAM  
Subsequent Product Code
FDF  
Date Received02/03/1997
Decision Date 04/17/1997
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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