Weck Hem-o-lok Auto Endo5 Ligating Clip Applier

Clip, Implantable

Teleflex Medical, Inc.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Weck Hem-o-lok Auto Endo5 Ligating Clip Applier.

Pre-market Notification Details

Device IDK142777
510k NumberK142777
Device Name:Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
ClassificationClip, Implantable
Applicant Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park,  NC  27709
ContactAshlea Ricci
CorrespondentAshlea Ricci
Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park,  NC  27709
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-26
Decision Date2014-12-19
Summary:summary

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