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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K252198
Device Name Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
Applicant
Medical Brands Laboratories B.V.
Weesperstraat 114
Diemen,  NL 1112AP
Applicant Contact Pieternella Bouter
Correspondent
Medical Brands Laboratories B.V.
Weesperstraat 114
Diemen,  NL 1112AP
Correspondent Contact Pieternella Bouter
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
FRO  
Date Received07/14/2025
Decision Date 04/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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