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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 K252903
Device Name Verruca-Freeze H Plus
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 Kaitlyn Clements
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/11/2025
Decision Date 10/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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