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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 K193339
Device Name GTK Veress Needles
Applicant
Guangzhou T.K Medical Instrument Co., Ltd.
A601, Guangzhou International Business Incubator, Guangzhou
Science Park
Guangzhou,  CN 510663
Applicant Contact Tracy Weng
Correspondent
Shenzhen Joyantech Consulting Co., Ltd
1713A, Block A, Zhongguan Times Square, Liuxian Avenue,
Xili Town, Nanshan
Shenzhen,  CN 518000
Correspondent Contact Christy Young
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
FHO  
Date Received12/02/2019
Decision Date 01/30/2020
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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