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510(k) K072278

BRK TRANSSEPTAL NEEDLE by St Jude Medical — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2007
Date Received
August 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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