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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
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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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