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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 K081082
Device Name U-CLIP UNI-FIRE, MODEL M65
Applicant
Medtronic, Inc.
3051 S. Newcombe Way
Lakewood,  CO  80227
Applicant Contact DAVID D COX
Correspondent
Medtronic, Inc.
3051 S. Newcombe Way
Lakewood,  CO  80227
Correspondent Contact DAVID D COX
Regulation Number878.4300
Classification Product Code
FZP  
Date Received04/16/2008
Decision Date 05/07/2008
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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