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510(k) K100799

FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 by Contract Medical Intl. GmbH — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2011
Date Received
March 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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