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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 K923983
Device Name PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT
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 Received08/07/1992
Decision Date 04/06/1993
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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