OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K112214
Device Name OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
Applicant
ST. JUDE MEDICAL NEUROMODULATION
6901 preston rd.
plano, 
TX 
75024

Applicant Contact penny houston
Correspondent
ST. JUDE MEDICAL NEUROMODULATION
6901 preston rd.
plano, 
TX 
75024

Correspodent Contact penny houston
Regulation Number 882.5880
Classification Product Code
GZB  
Date Received 08/02/2011
Decision Date 11/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No