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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 K020879
Device Name IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001
Applicant
Integrated Vascular Systems, Inc.
743 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact SUSAN TURNER
Correspondent
Integrated Vascular Systems, Inc.
743 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact SUSAN TURNER
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/18/2002
Decision Date 09/25/2002
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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