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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 K112349
Device Name VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
Applicant
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven,  CT  06473
Applicant Contact ANGELA V ARSDALE
Correspondent
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven,  CT  06473
Correspondent Contact ANGELA V ARSDALE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/16/2011
Decision Date 09/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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