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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 K001916
Device Name COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
Applicant
NOVARTIS NUTRITION CORP.
5320 WEST 23RD ST.
PO BOX 370
MINNEAPOLIS,  MN  55440
Applicant Contact SHARON MARTIN
Correspondent
NOVARTIS NUTRITION CORP.
5320 WEST 23RD ST.
PO BOX 370
MINNEAPOLIS,  MN  55440
Correspondent Contact SHARON MARTIN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/23/2000
Decision Date 02/16/2001
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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