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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vapocoolant Device
510(k) Number K261684
Device Name FreezeSpray TA
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
Classification Product Code
MLY  
Date Received05/21/2026
Decision Date 09/05/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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