ATRICURE DISSECTOR

Lamp, Surgical

ATRICURE, INC.

The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Dissector.

Pre-market Notification Details

Device IDK111020
510k NumberK111020
Device Name:ATRICURE DISSECTOR
ClassificationLamp, Surgical
Applicant ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester,  OH  45069
ContactJames L Lucky
CorrespondentJames L Lucky
ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester,  OH  45069
Product CodeFTD  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-12
Decision Date2011-06-09
Summary:summary

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