SEASPINE MONOPOLAR PROBE SYSYEM


Device Classification Name

stimulator, nerve

510(k) Number K111671
Device Name SEASPINE MONOPOLAR PROBE SYSYEM
Applicant
SEASPINE, INC.
2302 la mirada dr.
vista, 
CA 
92081 -7862

Applicant Contact dan miller
Correspondent
SEASPINE, INC.
2302 la mirada dr.
vista, 
CA 
92081 -7862

Correspodent Contact dan miller
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 06/15/2011
Decision Date 12/28/2011
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