RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS

Staple, Implantable

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Reliatack Articulating Reloadable Fixation Device With Standard Purchase Absorble Tacks.

Pre-market Notification Details

Device IDK140609
510k NumberK140609
Device Name:RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
ClassificationStaple, Implantable
Applicant COVIDIEN 60 Middletown Ave North Haven,  CT  06473
ContactClare Santulli
CorrespondentClare Santulli
COVIDIEN 60 Middletown Ave North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-10
Decision Date2014-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521202412 K140609 000
10884521202382 K140609 000
20884521726342 K140609 000
20884521726335 K140609 000
30884521726370 K140609 000
40884521202390 K140609 000

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