SUPERDIMENSION MARKER DELIVERY KIT


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K110093
Device Name SUPERDIMENSION MARKER DELIVERY KIT
Applicant
SUPERDIMENSION INC.
161 cheshire lane north
suite 100
minneapolis, 
MN 
55441

Applicant Contact jonathan kovach
Correspondent
SUPERDIMENSION INC.
161 cheshire lane north
suite 100
minneapolis, 
MN 
55441

Correspodent Contact jonathan kovach
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 01/12/2011
Decision Date 02/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No