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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Natural
510(k) Number K142656
Device Name Surgical Gut Suture
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 Number878.4830
Classification Product Code
GAL  
Date Received09/18/2014
Decision Date 01/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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