SURGIMAP (TM) SPINE


Device Classification Name

system, image processing, radiological

510(k) Number K111019
Device Name SURGIMAP (TM) SPINE
Applicant
NEMARIS INC
1425 k street n.w.
11th floor
washington, 
DC 
20005

Applicant Contact keith a barritt
Correspondent
NEMARIS INC
1425 k street n.w.
11th floor
washington, 
DC 
20005

Correspodent Contact keith a barritt
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/12/2011
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No