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FDA 510(k) Application Details - K042129
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K042129
Device Name
Set, Administration, Intravascular
Applicant
CEDIC S.R.L.
VIA LIBERAZIONE, 63/9
PESCHIERA BORROMEO MILAN(LOMB) 20068 IT
Other 510(k) Applications for this Company
Contact
GIANCARLO GAGLIARDONI
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
08/06/2004
Decision Date
01/27/2005
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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