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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 K123804
Device Name INSTAFLO BOWEL CATHETER SYSTEM KIT
Applicant
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Applicant Contact CHRIS STUKEL
Correspondent
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Correspondent Contact CHRIS STUKEL
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/10/2012
Decision Date 04/17/2013
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
Predetermined Change
Control Plan Authorized		 No
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