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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 K151309
Device Name Wartie Advanced Wart Remover or other proprietary name
Applicant
Youmedical Corp BV
Rijnsburgstraat 9-11
Amsterdam,  NL 1059 AT
Applicant Contact FRANCESCA MAPPA
Correspondent
Medical Device Approvals, Inc.
P.O. Box 1124
Bryn Mawr,  PA  19010
Correspondent Contact KATHLEEN JOHNSON
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/18/2015
Decision Date 08/14/2015
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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