ENDO-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 Endo-tube.

Pre-market Notification Details

Device IDK850664
510k NumberK850664
Device Name:ENDO-TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville,  NJ  08876
ContactAlberto Velex
CorrespondentAlberto Velex
BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville,  NJ  08876
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-20
Decision Date1985-06-21

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