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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 K002714
Device Name WARTNER WART REMOVAL SYSTEM
Applicant
Wartner Medical Products
25 Bellini Ave.
Brampton, Ontario,  CA L6T 3Z8
Applicant Contact JUDY MAGNER
Correspondent
Wartner Medical Products
25 Bellini Ave.
Brampton, Ontario,  CA L6T 3Z8
Correspondent Contact JUDY MAGNER
Regulation Number878.4350
Classification Product Code
GEH  
Date Received08/31/2000
Decision Date 11/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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