Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K042359
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K042359
Device Name
Shunt, Central Nervous System And Components
Applicant
MEDICAL DESIGNS, LLC
1210 W. 18TH ST.
NORTH CENTER, SUITE 104
SIOUX FALLS, SD 57104 US
Other 510(k) Applications for this Company
Contact
PAUL JOHN AXT
Other 510(k) Applications for this Contact
Regulation Number
882.5550
More FDA Info for this Regulation Number
Classification Product Code
JXG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2004
Decision Date
11/17/2004
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