WIDE SPACED QUATTRODE LEADS


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K072462
Device Name WIDE SPACED QUATTRODE LEADS
Applicant
ADVANCED NEUROMODULATION SYSTEMS
6901 preston rd.
plano, 
TX 
75024

Applicant Contact mia m ware
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
6901 preston rd.
plano, 
TX 
75024

Correspodent Contact mia m ware
Regulation Number 882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received 08/31/2007
Decision Date 10/11/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No