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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 K041681
Device Name ATRICURE DISSECTOR
Applicant
ATRICURE, INC.
6033 SCHUMACHER PARK DR.
WEST CHESTER,  OH  45069
Applicant Contact MARK JOB
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4580
Classification Product Code
FTD  
Date Received06/21/2004
Decision Date 07/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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