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FDA 510(k) Application Details - K102073
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K102073
Device Name
Set, Administration, Intravascular
Applicant
BENLAN, INC.
P.O. BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact
E.J. Smith
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
07/23/2010
Decision Date
11/08/2010
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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