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510(k) K142357

DuraSheath Introducer Sheath System by Contract Medical International, GmbH — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2015
Date Received
August 25, 2014
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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