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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K210104
Device Name SurroundScope System
Applicant
270surgical , Ltd.
4 Arie Regev St.
Netanya,  IL 4250212
Applicant Contact Avi Levy
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number884.1720
Classification Product Code
HET  
Date Received01/14/2021
Decision Date 07/08/2021
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
Predetermined Change
Control Plan Authorized		 No
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