CINCH ANCHOR, MODEL 1194


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K081208
Device Name CINCH ANCHOR, MODEL 1194
Applicant
ADVANCED NEUROMODULATION SYSTEMS
6901 preston rd.
plano, 
TX 
75024

Applicant Contact penny houston
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
6901 preston rd.
plano, 
TX 
75024

Correspodent Contact penny houston
Regulation Number 882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received 04/29/2008
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No