Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K032388
Device Classification Name
Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K032388
Device Name
Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty
Applicant
Cardinal Health
1500 WAUKEGAN RD.
MCGAW PARK, IL 60085 US
Other 510(k) Applications for this Company
Contact
SHARON NICHOLS
Other 510(k) Applications for this Contact
Regulation Number
882.5300
More FDA Info for this Regulation Number
Classification Product Code
MYU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2003
Decision Date
10/31/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact