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FDA 510(k) Application Details - K061727
Device Classification Name
Vessel Guard Or Cover, To Facilitate Revision Surgeries
More FDA Info for this Device
510(K) Number
K061727
Device Name
Vessel Guard Or Cover, To Facilitate Revision Surgeries
Applicant
W.L. GORE & ASSOCIATES,INC
1505 NORTH FOURTH ST.
FLAGSTAFF, AZ 86003-3000 US
Other 510(k) Applications for this Company
Contact
Michael Ivey
Other 510(k) Applications for this Contact
Regulation Number
870.3470
More FDA Info for this Regulation Number
Classification Product Code
MFX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/19/2006
Decision Date
08/07/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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