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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 K082619
Device Name SILS PORT, MODELS SILSPT5, SILSPT12
Applicant
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Applicant Contact ROBERT ZOTT
Correspondent
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Correspondent Contact ROBERT ZOTT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/09/2008
Decision Date 11/07/2008
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
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