COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON

Dilator, Esophageal

COOK ENDOSCOPY

The following data is part of a premarket notification filed by Cook Endoscopy with the FDA for Cook Endoscopy Esophageal Dilation Balloon.

Pre-market Notification Details

Device IDK061937
510k NumberK061937
Device Name:COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
ClassificationDilator, Esophageal
Applicant COOK ENDOSCOPY 4900 BETHANIA STATION RD. Winston-salem,  NC  27105
ContactMabel L Hunter
CorrespondentMabel L Hunter
COOK ENDOSCOPY 4900 BETHANIA STATION RD. Winston-salem,  NC  27105
Product CodeKNQ  
CFR Regulation Number876.5365 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-10
Decision Date2006-12-01
Summary:summary

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