FDA 510(k) Application Details - K101174

Device Classification Name Surgical Device, For Ablation Of Cardiac Tissue

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510(K) Number K101174
Device Name Surgical Device, For Ablation Of Cardiac Tissue
Applicant ATRICURE, INC.
6217 CENTER PARK DRIVE
WEST CHESTER, OH 45069 US
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Contact JAMES LUCKY
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Regulation Number 878.4400

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Classification Product Code OCL
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Date Received 04/27/2010
Decision Date 11/12/2010
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 N
Expedited Review



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