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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K240227
Device Name LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)
Applicant
LiNA Medical Aps
Formervangen 5
Glostrup,  DK DK-2600
Applicant Contact Barczak Katarzyna
Correspondent
MEDIcept, Inc.
200 Homer Avenue
Ashland,  MA  01721
Correspondent Contact Richelle Helman
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received01/26/2024
Decision Date 08/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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