PEDI-TUBE(R) STYLET

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 Pedi-tube(r) Stylet.

Pre-market Notification Details

Device IDK894857
510k NumberK894857
Device Name:PEDI-TUBE(R) STYLET
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville,  NJ  08876
ContactPeter Waeger
CorrespondentPeter Waeger
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 Received1989-07-31
Decision Date1989-10-03

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