DISPOSABLE STIMULATING ELECTRODE


Device Classification Name

stimulator, nerve

510(k) Number K111597
Device Name DISPOSABLE STIMULATING ELECTRODE
Applicant
NUVASIVE, INC.
7475 lusk blvd
san diego, 
CA 
92121

Applicant Contact sheila bruschi
Correspondent
NUVASIVE, INC.
7475 lusk blvd
san diego, 
CA 
92121

Correspodent Contact sheila bruschi
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 06/08/2011
Decision Date 10/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No