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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Enteral
510(k) Number K940555
Device Name SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
Applicant
Sandoz Nutrition
5320 W. Twenty Third St.
P.O. Box 370
Minneapolis,  MN  55440
Applicant Contact ROBERT J LANG
Correspondent
Sandoz Nutrition
5320 W. Twenty Third St.
P.O. Box 370
Minneapolis,  MN  55440
Correspondent Contact ROBERT J LANG
Regulation Number880.5725
Classification Product Code
LZH  
Date Received02/07/1994
Decision Date 02/01/1995
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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