SMITH & NEPHEW CDS SYSTEM


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K081491
Device Name SMITH & NEPHEW CDS SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 e brooks road
memphis, 
TN 
38116

Applicant Contact mason w robbins
Correspondent
SMITH & NEPHEW, INC.
1450 e brooks road
memphis, 
TN 
38116

Correspodent Contact mason w robbins
Regulation Number 892.1650
Classification Product Code
JAA  
Date Received 05/28/2008
Decision Date 06/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No