TECA ELITE DISPOSABLE CONCENTRIC NEEDLES


Device Classification Name

electrode, needle, diagnostic electromyograph

510(k) Number K112034
Device Name TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
Applicant
CAREFUSION 209, INC.
1850 deming way
middleton, 
WI 
53562

Applicant Contact glen hermanson
Correspondent
CAREFUSION 209, INC.
1850 deming way
middleton, 
WI 
53562

Correspodent Contact glen hermanson
Regulation Number 890.1385
Classification Product Code
IKT  
Date Received 07/15/2011
Decision Date 08/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No