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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 K231661
Device Name CryoThin™ Surgical System and Accessories
Applicant
Medinux (Tianjin) Technologies Co., Ltd.
Rm. 401, Unit 3, Bldg. K1
6 Haitai Fazhan 6th Rd., Huayuan Industrial Park
Tianjin,  CN 300384
Applicant Contact Diana Zhang
Correspondent
Medinux (Tianjin) Technologies Co., Ltd.
Rm. 401, Unit 3, Bldg. K1
6 Haitai Fazhan 6th Rd., Huayuan Industrial Park
Tianjin,  CN 300384
Correspondent Contact Diana Zhang
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/07/2023
Decision Date 11/27/2023
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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