Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K062909
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K062909
Device Name
Set, Administration, Intravascular
Applicant
BAXA CORP.
14445 GRASSLANDS DR.
ENGLEWOOD, CO 80112-7062 US
Other 510(k) Applications for this Company
Contact
KIMBERLY ZIZIK
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
09/27/2006
Decision Date
03/09/2007
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact