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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K173919
Device Name HX Device
Applicant
Human Extension , Ltd.
45 Hamada St.
Poleg Industrial Park, P.O. Box 8180
Netanya,  IL 4250574
Applicant Contact Dalit Doron
Correspondent
Orly Maor
25 Sirkin St.
Kfar Saba,  IL 4442156
Correspondent Contact Orly Maor
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
NAY  
Date Received12/22/2017
Decision Date 03/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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