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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K020919
Device Name ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
Applicant
AtriCure, Inc.
6033 Schumacher Park Dr.
West Chester,  OH  45069
Applicant Contact MARK L FRIEDMAN
Correspondent
AtriCure, Inc.
6033 Schumacher Park Dr.
West Chester,  OH  45069
Correspondent Contact MARK L FRIEDMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/21/2002
Decision Date 04/19/2002
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
Predetermined Change
Control Plan Authorized		 No
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