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FDA 510(k) Application Details - K121878
Device Classification Name
Surgical Device, For Ablation Of Cardiac Tissue
More FDA Info for this Device
510(K) Number
K121878
Device Name
Surgical Device, For Ablation Of Cardiac Tissue
Applicant
MEDTRONIC INC.
8200 CORAL SEA STREET NE
MAIL STOP MVS83
MOUNDS VIEW, MN 55112 US
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Contact
KARI CHRISTIANSON
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
OCL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/28/2012
Decision Date
11/02/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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