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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 K203481
Device Name CryoVIVE
Applicant
Recens Medical Inc.
908, SK V1 center, 830 Dongtansunhwan-daero
Hwaseong-si,  KR 18468
Applicant Contact Yeonui Lee
Correspondent
Mtech Group
7707 Fannin Street Ste 200-V111
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
MLY  
Date Received11/27/2020
Decision Date 05/13/2021
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
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