TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT


Device Classification Name

accelerator, linear, medical

510(k) Number K110971
Device Name TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT
Applicant
NAVOTEK MEDICAL LTD
1835 market st.
29th floor
philadelphia, 
PA 
19103

Applicant Contact steven b datlof
Correspondent
NAVOTEK MEDICAL LTD
1835 market st.
29th floor
philadelphia, 
PA 
19103

Correspodent Contact steven b datlof
Regulation Number 892.5050
Classification Product Code
IYE  
Subsequent Product Code
NEU  
Date Received 04/06/2011
Decision Date 01/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No