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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 K250742
Device Name Focused Cryotherapy System
Applicant
Focused Cryo, Inc.
1205 Johnson Ferry Rd.
Suite 136-336
Marietta,  GA  30068
Applicant Contact Yogi Patel
Correspondent
Focused Cryo, Inc.
1205 Johnson Ferry Rd.
Suite 136-336
Marietta,  GA  30068
Correspondent Contact Yogi Patel
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/11/2025
Decision Date 12/09/2025
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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