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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 K032271
Device Name WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
Applicant
WARTNER USA B.V.
65 AVA CRESCENT
RICHMOND HILL, ONTARIO,  CA L4B 2X5
Applicant Contact NANCY LUM-WILSON
Correspondent
WARTNER USA B.V.
65 AVA CRESCENT
RICHMOND HILL, ONTARIO,  CA L4B 2X5
Correspondent Contact NANCY LUM-WILSON
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/23/2003
Decision Date 09/10/2003
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
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