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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 K142547
Device Name Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
Applicant
COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Applicant Contact MARY MELLOWS
Correspondent
COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Correspondent Contact MARY MELLOWS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/10/2014
Decision Date 12/09/2014
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
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