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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 K140314
Device Name WARTIE WART REMOVER
Applicant
YONMEDICAL BV
PO BOX 2042
FAIRFIELD,  IA  52556
Applicant Contact KATHLEEN JOHNSON
Correspondent
YONMEDICAL BV
PO BOX 2042
FAIRFIELD,  IA  52556
Correspondent Contact KATHLEEN JOHNSON
Regulation Number878.4350
Classification Product Code
GEH  
Date Received02/10/2014
Decision Date 06/12/2014
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
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