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510(k) K193125

R2P Destination Slender Guiding Sheath by Terumo Medical Corporation — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2020
Date Received
November 12, 2019
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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