Premium Surgiclip III

Clip, Implantable

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Premium Surgiclip Iii.

Pre-market Notification Details

Device IDK142869
510k NumberK142869
Device Name:Premium Surgiclip III
ClassificationClip, Implantable
Applicant COVIDIEN 60 Middletown Avenue North Haven,  CT  06473
ContactMichael Koczocik
CorrespondentMichael Koczocik
COVIDIEN 60 Middletown Avenue North Haven,  CT  06473
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-01
Decision Date2014-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521517391 K142869 000

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