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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K260999
Device Name LoFric Elle Pro
Applicant
Wellspect AB
Amniogatan 1, P.O.Box 14
Se-431 51 Sweden
Mölndal,  SE
Applicant Contact Emad Ramzi
Correspondent
Wellspect AB
Amniogatan 1, P.O.Box 14
Se-431 51 Sweden
Mölndal,  SE
Correspondent Contact Emad Ramzi
Regulation Number876.5130
Classification Product Code
EZD  
Date Received03/26/2026
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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