Lapro-Clip Auto Suture Reusable Long Clip Applier

Clip, Implantable

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Lapro-clip Auto Suture Reusable Long Clip Applier.

Pre-market Notification Details

Device IDK143598
510k NumberK143598
Device Name:Lapro-Clip Auto Suture Reusable Long Clip Applier
ClassificationClip, Implantable
Applicant Covidien LLC 60 Middletown Ave North Haven,  CT  06473
ContactRebecca Magnanimo
CorrespondentRebecca Magnanimo
Covidien LLC 60 Middletown Ave North Haven,  CT  06473
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-18
Decision Date2015-03-12
Summary:summary

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