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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 K220674
Device Name TargetCool
Applicant
RecensMedical Inc.
908, SK V1 center, 830 Dongtansunhwan-daero
Hwaseong-si,  KR 18468
Applicant Contact Yeonui Lee
Correspondent
Mtech Group
7505 Fannin Street Ste 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
MLY  
Date Received03/08/2022
Decision Date 03/31/2022
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
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