Lehman Manometry Catheter

System, Gastrointestinal Motility (electrical)

Wilson-Cook Medical, Inc.

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Lehman Manometry Catheter.

Pre-market Notification Details

Device IDK160170
510k NumberK160170
Device Name:Lehman Manometry Catheter
ClassificationSystem, Gastrointestinal Motility (electrical)
Applicant Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem,  NC  27105
ContactDoris A. Hawks
CorrespondentDoris A. Hawks
Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem,  NC  27105
Product CodeFFX  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-27
Decision Date2016-06-20
Summary:summary

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