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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 K243042
Device Name Co-Ablation System with Sterile Co-Ablation Probe
Applicant
Hygea Medical Technology Co., Ltd.
Floor 6&7, W. Area Of Bldg. # 8, #30 Yuhua Rd.,
Shunyi
Beijing,  CN 101318
Applicant Contact Xingtong Jiang
Correspondent
Hygea Medical Technology Co., Ltd.
Floor 6&7, W. Area Of Bldg. # 8, #30 Yuhua Rd.,
Shunyi
Beijing,  CN 101318
Correspondent Contact Xingtong Jiang
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/27/2024
Decision Date 01/29/2025
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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