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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 K142793
Device Name AbbVie PEG
Applicant
AbbVie , Inc.
1 N. Waukegan Rd.
North Chicago,  IL  60064
Applicant Contact Katherine Wortley
Correspondent
AbbVie , Inc.
1 N. Waukegan Rd.
North Chicago,  IL  60064
Correspondent Contact Katherine Wortley
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/26/2014
Decision Date 01/14/2015
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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