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FDA 510(k) Application Details - K955533
Device Classification Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
More FDA Info for this Device
510(K) Number
K955533
Device Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Applicant
W.L. GORE & ASSOCIATES,INC
1505 N. FOURTH ST.
POB 2200
FLAGSTAFF, AZ 86003-2200 US
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Contact
TIMOTHY J RYNN
Other 510(k) Applications for this Contact
Regulation Number
870.3450
More FDA Info for this Regulation Number
Classification Product Code
DYF
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More FDA Info for this Product Code
Date Received
12/05/1995
Decision Date
05/15/1996
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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