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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 K053255
Device Name NEXUS LIGATING CLIP
Applicant
MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL
540 COLLEGE STREET
BELLAIRE,  TX  77401
Applicant Contact LISA S JONES
Correspondent
MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL
540 COLLEGE STREET
BELLAIRE,  TX  77401
Correspondent Contact LISA S JONES
Regulation Number878.4300
Classification Product Code
FZP  
Date Received11/21/2005
Decision Date 03/14/2006
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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