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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
510(k) Number K883587
Device Name BIOSEARCH 3600 ENTRI FEEDING PUMP
Applicant
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Applicant Contact JOHN CARSELLO
Correspondent
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Correspondent Contact JOHN CARSELLO
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/23/1988
Decision Date 11/08/1988
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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