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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 K133202
Device Name HEM-O-LOK LIGATING CLIP
Applicant
TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact ASHLEA RICCI
Correspondent
TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact ASHLEA RICCI
Regulation Number878.4300
Classification Product Code
FZP  
Date Received10/17/2013
Decision Date 12/03/2013
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
Predetermined Change
Control Plan Authorized		 No
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