ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

Staple, Implantable

COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES

The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As United States with the FDA for Absorbatack 5mm Single Use Absorbable Fixation Device.

Pre-market Notification Details

Device IDK091900
510k NumberK091900
Device Name:ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
ClassificationStaple, Implantable
Applicant COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven,  CT  06473
ContactRebecca Ronner
CorrespondentRebecca Ronner
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-25
Decision Date2009-07-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10613830159380 K091900 000
10613830159373 K091900 000
20884523006152 K091900 000

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