Zimmon Needle Knife Papillotome

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Wilson-Cook Medical, Inc. / Cook Endoscopy

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. / Cook Endoscopy with the FDA for Zimmon Needle Knife Papillotome.

Pre-market Notification Details

Device IDK171993
510k NumberK171993
Device Name:Zimmon Needle Knife Papillotome
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem,  NC  27105
ContactDoris A. Hawks
CorrespondentDoris A. Hawks
Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem,  NC  27105
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-03
Decision Date2017-08-17
Summary:summary

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