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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 K062057
Device Name U-CLIP DEVICE, MODEL NC65
Applicant
MEDTRONIC VASCULAR
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55428
Applicant Contact DAVID D COX
Correspondent
MEDTRONIC VASCULAR
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55428
Correspondent Contact DAVID D COX
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/20/2006
Decision Date 08/02/2006
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
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