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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 K030838
Device Name WARTNER PRO
Applicant
Wartner Medical Products
65 Ava Crescent
Richmond Hill, Ontario,  CA L4B 2X5
Applicant Contact NANCY LUM-WILSON
Correspondent
Wartner Medical Products
65 Ava Crescent
Richmond Hill, Ontario,  CA L4B 2X5
Correspondent Contact NANCY LUM-WILSON
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/17/2003
Decision Date 06/27/2003
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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