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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, feeding
510(k) Number K912575
Device Name EXTERNAL GASTROSTOMY TUBE RETAINER
Applicant
SANDOZ NUTRITION
5320 WEST TWENTY THIRD ST.
P.O. BOX 370
MINNEAPOLIS,  MN  55440
Applicant Contact ROBERT J LANG
Correspondent
SANDOZ NUTRITION
5320 WEST TWENTY THIRD ST.
P.O. BOX 370
MINNEAPOLIS,  MN  55440
Correspondent Contact ROBERT J LANG
Regulation Number876.5980
Classification Product Code
FPD  
Date Received06/12/1991
Decision Date 11/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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