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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 K873444
Device Name ENTECH ENTERAL PUMP AND SET
Applicant
Entech, Inc.
Rte. 22 E.
Lebanon,  NJ  08833
Applicant Contact LAURENCE A POTTER
Correspondent
Entech, Inc.
Rte. 22 E.
Lebanon,  NJ  08833
Correspondent Contact LAURENCE A POTTER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/27/1987
Decision Date 11/02/1987
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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