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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 K210529
Device Name Dr. Yglo Wart Remover
Applicant
Theotclab Healthcare B.V.
Fred. Roeskestraat 115
Amsterdam,  NL 1076EE
Applicant Contact Albert Swane
Correspondent
Medical Device Approvals, Inc.
104 E. Harrison Ave.
Fairfield,  IA  52556
Correspondent Contact Kathleen Johnson
Regulation Number878.4350
Classification Product Code
GEH  
Date Received02/23/2021
Decision Date 05/06/2021
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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