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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 K190190
Device Name WV1 Endoscope
Applicant
270Surgical Ltd
4 Arie Regev Street
Natanya,  IL 4250212
Applicant Contact Avi Levy
Correspondent
Hogan Lovells US LLP
1735 Market Street, Suite 230
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
GCJ  
Date Received02/01/2019
Decision Date 11/01/2019
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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