Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K012879
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K012879
Device Name
Set, Administration, Intravascular
Applicant
EXELINT INTL. CO.
5840 WEST CENTINELA AVE.
LOS ANGELES, CA 90045 US
Other 510(k) Applications for this Company
Contact
ARMAND HAMID
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
08/28/2001
Decision Date
01/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact