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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lamp, surgical
510(k) Number K111020
Device Name ATRICURE DISSECTOR
Applicant
ATRICURE, INC.
6217 CENTRE PARK DRIVE
WEST CHESTER,  OH  45069
Applicant Contact JAMES L LUCKY
Correspondent
ATRICURE, INC.
6217 CENTRE PARK DRIVE
WEST CHESTER,  OH  45069
Correspondent Contact JAMES L LUCKY
Regulation Number878.4580
Classification Product Code
FTD  
Subsequent Product Code
GDI  
Date Received04/12/2011
Decision Date 06/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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