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FDA 510(k) Application Details - K080509
Device Classification Name
Surgical Device, For Ablation Of Cardiac Tissue
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510(K) Number
K080509
Device Name
Surgical Device, For Ablation Of Cardiac Tissue
Applicant
MEDTRONIC INC.
7601 NORTHLAND DRIVE
MINNEAPOLIS, MN 55428 US
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PREETI JAIN
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Regulation Number
878.4400
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Classification Product Code
OCL
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Date Received
02/25/2008
Decision Date
05/05/2008
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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