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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 K142777
Device Name Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
Applicant
Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park,  NC  27709
Applicant Contact Ashlea Ricci
Correspondent
Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park,  NC  27709
Correspondent Contact Ashlea Ricci
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/26/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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