Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K033301
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K033301
Device Name
Set, Administration, Intravascular
Applicant
CODAN US CORP.
3511 WEST SUNFLOWER AVE.
SANTA ANA, CA 92704-6944 US
Other 510(k) Applications for this Company
Contact
ROHIT PATEL
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
10/14/2003
Decision Date
03/04/2004
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