PERMACOL SURGICAL IMPLANT

Mesh, Surgical

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Permacol Surgical Implant.

Pre-market Notification Details

Device IDK120605
510k NumberK120605
Device Name:PERMACOL SURGICAL IMPLANT
ClassificationMesh, Surgical
Applicant Covidien LLC 15 CROSBY DR Bedford,  MA  01730
ContactJames Mcmahon
CorrespondentJames Mcmahon
Covidien LLC 15 CROSBY DR Bedford,  MA  01730
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-28
Decision Date2012-05-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884523000153 K120605 000
10884523000054 K120605 000
10884523000047 K120605 000
10884523000245 K120605 000
10884523000221 K120605 000
10884523000207 K120605 000
10884523000191 K120605 000
10884523000184 K120605 000
10884523000016 K120605 000
10884523000061 K120605 000
10884523000078 K120605 000
10884523000085 K120605 000
10884523000214 K120605 000
10884523000177 K120605 000
10884523000160 K120605 000
10884523000139 K120605 000
10884523000122 K120605 000
10884523000115 K120605 000
10884523000108 K120605 000
10884523000092 K120605 000
10884523000146 K120605 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.