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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 K981323
Device Name COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
Applicant
NOVARTIS NUTRITION CORP.
5320 WEST 23RD ST.
PO BOX 370
MINNEAPOLIS,  MN  55440
Applicant Contact ROBERT J LANG
Correspondent
NOVARTIS NUTRITION CORP.
5320 WEST 23RD ST.
PO BOX 370
MINNEAPOLIS,  MN  55440
Correspondent Contact ROBERT J LANG
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/13/1998
Decision Date 10/09/1998
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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