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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 K032980
Device Name AMI REPROCESSED MULTIPLE CLIP APPLIERS
Applicant
Vanguard Medical Concepts, Inc.
3706 76th St.
Lubbock,  TX  79423
Applicant Contact MARK ALDANA
Correspondent
Vanguard Medical Concepts, Inc.
3706 76th St.
Lubbock,  TX  79423
Correspondent Contact MARK ALDANA
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/24/2003
Decision Date 12/18/2003
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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