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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 K161294
Device Name Compound W Wart Removal System Dual Power
Applicant
Medtech Products, Inc.
660 White Plains Rd.
Tarrytown,  NY  10591
Applicant Contact JEAN BOYKO
Correspondent
Emergo Global Consulting, LLC
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact KATHRYN A. CORESSEL
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/09/2016
Decision Date 09/15/2016
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 Yes
Predetermined Change
Control Plan Authorized		 No
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