Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K050720
Device Classification Name
Device, Monitoring, Intracranial Pressure
More FDA Info for this Device
510(K) Number
K050720
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
INTEGRA NEUROSCIENCES
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
Other 510(k) Applications for this Company
Contact
NANCY A MATHEWSON
Other 510(k) Applications for this Contact
Regulation Number
882.1620
More FDA Info for this Regulation Number
Classification Product Code
GWM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2005
Decision Date
05/11/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact