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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name trocar
510(k) Number K122587
Model 407200, 407201, 407205, 407206, 407207, G407208
Device Name BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
Original Applicant
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka,  MN  55345 2126
Original Contact harlan jones
Regulation Number870.1390
Classification Product Code
DRC  
Date Received08/24/2012
Decision Date 02/07/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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