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510(k) K122587

BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 by St Jude Medical — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2013
Date Received
August 24, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type

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