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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K032973
Device Name REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
Applicant
VANGUARD MEDICAL CONCEPTS, INC.
3706 76TH STREET
LUBBOCK,  TX  79423
Applicant Contact MARK ALDANA
Correspondent
VANGUARD MEDICAL CONCEPTS, INC.
3706 76TH STREET
LUBBOCK,  TX  79423
Correspondent Contact MARK ALDANA
Regulation Number878.4750
Classification Product Code
GDW  
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
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