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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 K833621
Device Name ENTRI FLEX FEEDING TUBE
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
SOMERVILLE,  NJ  08876
Applicant Contact H Y MANLULU
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
SOMERVILLE,  NJ  08876
Correspondent Contact H Y MANLULU
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/14/1983
Decision Date 11/28/1983
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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