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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K221995
Device Name Gas Insufflator
Applicant
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area
Zonghan Subdistrict
Cixi,  CN 315300
Applicant Contact Guofang Ma
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 Number884.1730
Classification Product Code
HIF  
Date Received07/06/2022
Decision Date 03/28/2023
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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