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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 K901683
Device Name IMPROVED BAKER TWIN-CUFF SUMP TUBE
Applicant
Bissell Medical Products, Inc.
608 S. Washington St. #
201
Naperville,  IL  60540
Applicant Contact SHARYL A DEWANE
Correspondent
Bissell Medical Products, Inc.
608 S. Washington St. #
201
Naperville,  IL  60540
Correspondent Contact SHARYL A DEWANE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/10/1990
Decision Date 06/27/1990
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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