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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 K030841
Device Name COOK GASTRIC SIZING BALLOON CATHETER
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402 -0489
Applicant Contact CAROL ZWISSLER
Correspondent
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402 -0489
Correspondent Contact CAROL ZWISSLER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/17/2003
Decision Date 07/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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