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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 K243487
Device Name CryoFreeze Wart and Skin Tag Remover
Applicant
Cryosurgery, Inc.
5829 Old Harding Pike
Nashville,  TN  37205
Applicant Contact Ronald McDow
Correspondent
Cryosurgery, Inc.
5829 Old Harding Pike
Nashville,  TN  37205
Correspondent Contact Ronald McDow
Regulation Number878.4350
Classification Product Code
GEH  
Date Received11/08/2024
Decision Date 03/13/2025
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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