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510(k) K250659

LoFric Origo by Wellspect AB — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2025
Date Received
March 5, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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