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FDA 510(k) Application Details - K964067
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K964067
Device Name
Set, Administration, Intravascular
Applicant
W.L. GORE & ASSOCIATES,INC
1505 NORTH FOURTH ST.
P.O. BOX 2200
FLAGSTAFF, AZ 86003-2200 US
Other 510(k) Applications for this Company
Contact
DAWN LOPEZ
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/10/1996
Decision Date
06/05/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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