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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 K190592
Device Name YelloPort Elite Port Access System
Applicant
Surgical Innovations Limited
Clayton Wood House
6 Clayton Wood Bank
Leeds,  GB LS16 6QZ
Applicant Contact Shazia Chaudhry
Correspondent
Surgical Innovations Limited
Clayton Wood House
6 Clayton Wood Bank
Leeds,  GB LS16 6QZ
Correspondent Contact Shazia Chaudhry
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/07/2019
Decision Date 04/29/2019
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
Recalls CDRH Recalls
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