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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 K172373
Device Name Compound W Nitro-Freeze
Applicant
Medtech Products, Inc.
660 White Plains Rd.
Suite 250
Tarrytown,  NY  10591
Applicant Contact Jean Boyko
Correspondent
Medtech Products, Inc.
660 White Plains Rd.
Suite 250
Tarrytown,  NY  10591
Correspondent Contact Vincent Argiro
Regulation Number878.4350
Classification Product Code
GEH  
Date Received08/07/2017
Decision Date 11/02/2017
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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