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FDA 510(k) Application Details - K032973
Device Classification Name
Staple, Implantable
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510(K) Number
K032973
Device Name
Staple, Implantable
Applicant
VANGUARD MEDICAL CONCEPTS, INC.
3706 76TH STREET
LUBBOCK, TX 79423 US
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Contact
MARK ALDANA
Other 510(k) Applications for this Contact
Regulation Number
878.4750
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Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
09/24/2003
Decision Date
12/18/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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