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FDA 510(k) Application Details - K050459
Device Classification Name
Surgical Device, For Ablation Of Cardiac Tissue
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510(K) Number
K050459
Device Name
Surgical Device, For Ablation Of Cardiac Tissue
Applicant
ATRICURE, INC.
6033 SCHUMACHER PARK DR.
WEST CHESTER, OH 45069 US
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Contact
ELSA ABRUZZO
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Regulation Number
878.4400
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Classification Product Code
OCL
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More FDA Info for this Product Code
Date Received
02/23/2005
Decision Date
06/13/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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