FDA 510(k) Application Details - K013392

Device Classification Name Surgical Device, For Ablation Of Cardiac Tissue

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510(K) Number K013392
Device Name Surgical Device, For Ablation Of Cardiac Tissue
Applicant MEDTRONIC VASCULAR
1015 GRAMSIE RD
SHOREVIEW, MN 55126-3082 US
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Contact SCOTT CANDY
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Regulation Number 878.4400

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Classification Product Code OCL
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Date Received 10/15/2001
Decision Date 01/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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