EPIDUCER LEAD DELIVERY SYSTEM


Device Classification Name

electrode, spinal epidural

510(k) Number K110609
Device Name EPIDUCER LEAD DELIVERY SYSTEM
Applicant
ST. JUDE MEDICAL
6901 preston road
plano, 
TX 
75024

Applicant Contact rashmi moza
Correspondent
ST. JUDE MEDICAL
6901 preston road
plano, 
TX 
75024

Correspodent Contact rashmi moza
Regulation Number 882.5880
Classification Product Code
LHG  
Subsequent Product Code
GZB  
Date Received 03/03/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No