FDA 510(k) Application Details - K123733

Device Classification Name Surgical Device, For Ablation Of Cardiac Tissue

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510(K) Number K123733
Device Name Surgical Device, For Ablation Of Cardiac Tissue
Applicant MEDTRONIC INC.
8200 CORAL SEA STREET NE
MS MVS83
MOUNDS VIEW, MN 55112 US
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Contact KARI CHRISTIANSON
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Regulation Number 878.4400

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Classification Product Code OCL
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Date Received 12/05/2012
Decision Date 04/01/2013
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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