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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 K251524
Device Name Dr. Yglo Skin Tag Remover
Applicant
Theotclab Healthcare B.V.
Fred. Roeskestraat 100
Amsterdam,  NL 1076
Applicant Contact Jill Matzat
Correspondent
Theotclab Healthcare B.V.
Fred. Roeskestraat 100
Amsterdam,  NL 1076
Correspondent Contact Jill Matzat
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/16/2025
Decision Date 01/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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