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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 K232970
Device Name Hem-o-lok® Ligating Clips
Applicant
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Hope West
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Hope West
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/21/2023
Decision Date 01/12/2024
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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