ASPISAFE GASTRIC TUBE

Tube, Nasogastric

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Aspisafe Gastric Tube.

Pre-market Notification Details

Device IDK961711
510k NumberK961711
Device Name:ASPISAFE GASTRIC TUBE
ClassificationTube, Nasogastric
Applicant B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem,  PA  18018
ContactMark S Alsberge
CorrespondentMark S Alsberge
B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem,  PA  18018
Product CodeBSS  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-02
Decision Date1997-06-11
Summary:summary

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