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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K210116
Device Name Video Endoscopy System, 3D Video Endoscopy System
Applicant
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area,
Zonghan Subdistrict
Cixi,  CN 315300
Applicant Contact Ma Guofang
Correspondent
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area,
Zonghan Subdistrict
Cixi,  CN 315300
Correspondent Contact Guofang Ma
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
FGB   GCJ  
Date Received01/19/2021
Decision Date 10/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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