REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS

Staple, Implantable

VANGUARD MEDICAL CONCEPTS, INC.

The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Reprocessed Disposable Cutters, Staplers And Appliers.

Pre-market Notification Details

Device IDK032973
510k NumberK032973
Device Name:REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
ClassificationStaple, Implantable
Applicant VANGUARD MEDICAL CONCEPTS, INC. 3706 76TH STREET Lubbock,  TX  79423
ContactMark Aldana
CorrespondentMark Aldana
VANGUARD MEDICAL CONCEPTS, INC. 3706 76TH STREET Lubbock,  TX  79423
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-24
Decision Date2003-12-18
Summary:summary

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