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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 K161758
Device Name Weck Auto Endo10 Automatic Endoscopic Clip Applier
Applicant
TELEFLEX MEDICAL
3015 CARRINGTON MILL BLVD
MORRISVILLE,  NC  27560
Applicant Contact HOLLY HALLOCK
Correspondent
TELEFLEX MEDICAL
3015 CARRINGTON MILL BLVD
MORRISVILLE,  NC  27560
Correspondent Contact HOLLY HALLOCK
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received06/27/2016
Decision Date 09/07/2016
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
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