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510(k) K060190

SUPER SHEATH XL INTRODUCER SHEATH by Togo Medikit Co., Ltd. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2006
Date Received
January 24, 2006
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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