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510(k) K192422

Steerable Introducer 12F by Freudenberg Medical, LLC — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2019
Date Received
September 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

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