ENTRI FLEX FEEDING TUBE

Tubes, Gastrointestinal (and Accessories)

BIOSEARCH MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Entri Flex Feeding Tube.

Pre-market Notification Details

Device IDK833621
510k NumberK833621
Device Name:ENTRI FLEX FEEDING TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant BIOSEARCH MEDICAL PRODUCTS, INC. Somerville,  NJ  08876
ContactH Y Manlulu
CorrespondentH Y Manlulu
BIOSEARCH MEDICAL PRODUCTS, INC. Somerville,  NJ  08876
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-14
Decision Date1983-11-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521518872 K833621 000
10884521518810 K833621 000

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