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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 K201805
Device Name VersaOne Reusable Positioning Trocar System
Applicant
Covidien
60 Middletown Avenue
North Haven,  CT  06473
Applicant Contact Stephanie Wilde
Correspondent
Covidien
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Stephanie Wilde
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/01/2020
Decision Date 08/26/2020
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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