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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
510(k) Number K050459
Device Name ATRICURE ISOLATOR TRANSPOLAR PEN
Applicant
ATRICURE, INC.
6033 SCHUMACHER PARK DR.
WEST CHESTER,  OH  45069
Applicant Contact ELSA ABRUZZO
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4400
Classification Product Code
OCL  
Date Received02/23/2005
Decision Date 06/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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