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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K871019
Device Name ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET
Applicant
ENTECH, INC.
ROUTE 22 EAST
LEBANON,  NJ  08833
Applicant Contact LAURENCE A POTTER
Correspondent
ENTECH, INC.
ROUTE 22 EAST
LEBANON,  NJ  08833
Correspondent Contact LAURENCE A POTTER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/16/1987
Decision Date 06/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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