DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH

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 Dobbhoff(r) Endoenteric Gastric Decompression Cath.

Pre-market Notification Details

Device IDK900563
510k NumberK900563
Device Name:DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH
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 Received1990-02-07
Decision Date1990-08-02

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