Signia Four-Bay Smart Charger (to Be Used With Signia Stapler)

Staple, Implantable

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Signia Four-bay Smart Charger (to Be Used With Signia Stapler).

Pre-market Notification Details

Device IDK170348
510k NumberK170348
Device Name:Signia Four-Bay Smart Charger (to Be Used With Signia Stapler)
ClassificationStaple, Implantable
Applicant Covidien 60 Middletown Avenue North Haven,  CT  06473
ContactKatherine Y. Choi
CorrespondentKatherine Y. Choi
Covidien 60 Middletown Avenue North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-03
Decision Date2017-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521543850 K170348 000

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