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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 K173323
Device Name AnastoClip GC Closure System
Applicant
LeMaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Applicant Contact Xiang Zhang
Correspondent
LeMaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Correspondent Contact Xiang Zhang
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
HBT  
Date Received10/20/2017
Decision Date 03/08/2018
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
Recalls CDRH Recalls
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