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FDA 510(k) Application Details - K122587
Device Classification Name
Trocar
More FDA Info for this Device
510(K) Number
K122587
Device Name
Trocar
Applicant
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA, MN 55345-2126 US
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Contact
HARLAN JONES
Other 510(k) Applications for this Contact
Regulation Number
870.1390
More FDA Info for this Regulation Number
Classification Product Code
DRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/24/2012
Decision Date
02/07/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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