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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 K210495
Device Name Port Access System
Applicant
Surgical Innovations Limited
Clayton Wood House, 6 Clayton Wood Bank
Leeds,  GB LS16 6QZ
Applicant Contact Stephen Seed
Correspondent
Surgical Innovations Limited
Clayton Wood House, 6 Clayton Wood Bank
Leeds,  GB LS16 6QZ
Correspondent Contact Stephen Seed
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/22/2021
Decision Date 06/18/2021
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
Recalls CDRH Recalls
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