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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 K132658
Device Name HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
Applicant
TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact ASHLEA RICCI, RAC
Correspondent
TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact ASHLEA RICCI, RAC
Regulation Number878.4300
Classification Product Code
FZP  
Date Received08/26/2013
Decision Date 11/27/2013
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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