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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 K051125
Device Name IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
Applicant
Abbott Laboratories
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact KIM SMITH-SERVANCE
Correspondent
Abbott Laboratories
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact KIM SMITH-SERVANCE
Regulation Number878.4300
Classification Product Code
FZP  
Date Received05/03/2005
Decision Date 06/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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