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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K873441
Device Name BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE
Applicant
BISSELL MEDICAL PRODUCTS, INC.
135 SOUTH LASALLE ST.
CHICAGO,  IL  60603
Applicant Contact SHARYL A DEWANE
Correspondent
BISSELL MEDICAL PRODUCTS, INC.
135 SOUTH LASALLE ST.
CHICAGO,  IL  60603
Correspondent Contact SHARYL A DEWANE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/27/1987
Decision Date 10/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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