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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 K003047
Device Name AMBULATORY ENTERAL NUTRITION PUMP
Applicant
ROSS PRODUCT DIV. ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215 -1724
Applicant Contact YUKA HENDERSHOT
Correspondent
ROSS PRODUCT DIV. ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215 -1724
Correspondent Contact YUKA HENDERSHOT
Regulation Number880.5725
Classification Product Code
LZH  
Date Received09/29/2000
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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