EEA HEMORRHOID STAPLER & ACCESSORIES

Staple, Implantable

SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN

The following data is part of a premarket notification filed by Surgical Devices, A Global Business Unit Covidien with the FDA for Eea Hemorrhoid Stapler & Accessories.

Pre-market Notification Details

Device IDK083781
510k NumberK083781
Device Name:EEA HEMORRHOID STAPLER & ACCESSORIES
ClassificationStaple, Implantable
Applicant SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN 60 Middletown Ave North Haven,  CT  06473
ContactFrank Gianelli
CorrespondentFrank Gianelli
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN 60 Middletown Ave North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-19
Decision Date2009-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521047560 K083781 000
20884521047515 K083781 000

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