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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clip, implantable
510(k) Number K143598
Device Name Lapro-Clip Auto Suture Reusable Long Clip Applier
Covidien LLC
60 Middletown Ave
North Haven,  CT  06473
Applicant Contact Rebecca Magnanimo
Covidien LLC
60 Middletown Ave
North Haven,  CT  06473
Correspondent Contact Rebecca Magnanimo
Regulation Number878.4300
Classification Product Code
Date Received12/18/2014
Decision Date 03/12/2015
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