ULTRASHARP CONCENTRIC NEEDLES


Device Classification Name

electrode, needle, diagnostic electromyograph

510(k) Number K080914
Device Name ULTRASHARP CONCENTRIC NEEDLES
Applicant
ROCHESTER ELECTRO MEDICAL, INC.
4212 cypress gulch drive
lutz, 
FL 
33559

Applicant Contact charles c berkins
Correspondent
ROCHESTER ELECTRO MEDICAL, INC.
4212 cypress gulch drive
lutz, 
FL 
33559

Correspodent Contact charles c berkins
Regulation Number 890.1385
Classification Product Code
IKT  
Date Received 04/01/2008
Decision Date 07/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No