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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 K172835
Device Name GRI-Alleset Veress Needle
GRI Medical and Electronic Technology Co., Ltd.
105 Honggao Road, Xiuzhou Industry Zone
Jiaxing,  CN 314031
Applicant Contact Martin Paugh
Sharon Marrow
2907 Cherry Branch Drive
Knoxville,  TN  37948
Correspondent Contact Sharon Marrow
Regulation Number884.1730
Classification Product Code
Date Received09/19/2017
Decision Date 06/11/2018
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