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FDA 510(k) Application Details - K013250
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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510(K) Number
K013250
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 WEST KILTIE LN.
FLAGSTAFF, AZ 86001 US
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Contact
TIMOTHY J RYNN
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Regulation Number
870.3450
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Classification Product Code
DSY
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More FDA Info for this Product Code
Date Received
09/28/2001
Decision Date
10/26/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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