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510(k) K153246

PTFE Super Sheath Introducer 2.1 by Medcomp (Medical Components, Inc.) — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2016
Date Received
November 9, 2015
Clearance Type
Special
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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