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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 K920493
Device Name PEG PREP TRAY
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
KNT  
Date Received02/03/1992
Decision Date 01/04/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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