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FDA 510(k) Application Details - K090202
Device Classification Name
Surgical Device, For Ablation Of Cardiac Tissue
More FDA Info for this Device
510(K) Number
K090202
Device Name
Surgical Device, For Ablation Of Cardiac Tissue
Applicant
NCONTACT SURGICAL, INC.
1001 AVIATION PARKWAY
SUITE 400
MORRISVILLE, NC 27560 US
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Contact
JANE RICUPERO
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Regulation Number
878.4400
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Classification Product Code
OCL
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More FDA Info for this Product Code
Date Received
01/27/2009
Decision Date
02/17/2009
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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