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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 K152081
Device Name Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
Applicant
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact Ashlea Ricci
Correspondent
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact Ashlea Ricci
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/27/2015
Decision Date 08/26/2015
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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