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510(k) K121504

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2012
Date Received
May 21, 2012
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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