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510(k) K260999

LoFric Elle Pro by Wellspect AB — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2026
Date Received
March 26, 2026
Clearance Type
Special
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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