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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K190052
Device Name Radio Frequency Ablation System
Applicant
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
#1 Xinxing Yilu Rd., Emerging Industrial Cluster Area
Zonghan Subdistrict
Cixi,  CN 315300
Applicant Contact Guofang Ma
Correspondent
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
#1 Xinxing Yilu Rd., Emerging Industrial Cluster Area
Zonghan Subdistrict
Cixi,  CN 315300
Correspondent Contact Guofang Ma
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/11/2019
Decision Date 06/25/2019
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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