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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 K232401
Device Name Disposable Veress Needles
Hangzhou Kangji Medical Instrument Co., Ltd.
No. 1668 Chunjiang East Road, Economic Development Zone
Hangzhou,  CN 311501
Applicant Contact Martin Sun
Shanghai Ling Fu Technology Co., Ltd.
4F No. 585-2, Wanyuan Rd. Minhang District
Shanghai,  CN 201102
Correspondent Contact Esther Zhang
Regulation Number884.1730
Classification Product Code
Subsequent Product Code
Date Received08/10/2023
Decision Date 12/14/2023
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