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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 K212214
Device Name HandX
Applicant
Human Xtensions , Ltd.
4 Meir Ariel St.
Netanya,  IL 4250574
Applicant Contact Maija Wallenstein
Correspondent
Hogan Lovells US LLP
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Randy J Prebula
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
NAY  
Date Received07/15/2021
Decision Date 09/13/2021
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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