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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 K891575
Device Name COMPAT ENTERAL FEED PUMP 199235 & 199240
Applicant
Sandoz Nutrition
5320 W. Twenty Third St.
P.O. Box 370
Minneapolis,  MN  55440
Applicant Contact EGBERG, PH.D.
Correspondent
Sandoz Nutrition
5320 W. Twenty Third St.
P.O. Box 370
Minneapolis,  MN  55440
Correspondent Contact EGBERG, PH.D.
Regulation Number880.5725
Classification Product Code
LZH  
Date Received03/20/1989
Decision Date 09/12/1989
Decision Substantially Equivalent (SESE)
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
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