Hemospray Endoscopic Hemostat

Hemostatic Device For Endoscopic Gastrointestinal Use

Wilson-Cook Medical, Inc

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Hemospray Endoscopic Hemostat.

Pre-market Notification Details

Device IDK200972
510k NumberK200972
Device Name:Hemospray Endoscopic Hemostat
ClassificationHemostatic Device For Endoscopic Gastrointestinal Use
Applicant Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem,  NC  27105
ContactMarge Walls-walker
CorrespondentMarge Walls-walker
Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem,  NC  27105
Product CodeQAU  
CFR Regulation Number878.4456 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-13
Decision Date2020-06-10

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