IMPACT BALLOON DILATION CATHETER

Dilator, Esophageal

B. BRAUN/MCGAW

The following data is part of a premarket notification filed by B. Braun/mcgaw with the FDA for Impact Balloon Dilation Catheter.

Pre-market Notification Details

Device IDK983373
510k NumberK983373
Device Name:IMPACT BALLOON DILATION CATHETER
ClassificationDilator, Esophageal
Applicant B. BRAUN/MCGAW 824 12TH AVE. Bethlehem,  PA  18018 -0027
ContactMark S Alsberge
CorrespondentMark S Alsberge
B. BRAUN/MCGAW 824 12TH AVE. Bethlehem,  PA  18018 -0027
Product CodeKNQ  
CFR Regulation Number876.5365 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-24
Decision Date1999-06-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.