Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K001096
Device Classification Name
Cover, Burr Hole
More FDA Info for this Device
510(K) Number
K001096
Device Name
Cover, Burr Hole
Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE, FL 32935 US
Other 510(k) Applications for this Company
Contact
DAVID M LEE
Other 510(k) Applications for this Contact
Regulation Number
882.5250
More FDA Info for this Regulation Number
Classification Product Code
GXR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/04/2000
Decision Date
10/25/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact