TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K080871
Device Name TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
Applicant
NUCLETRON CORPORATION
8671 robert fulton dr.
columbia, 
MD 
21046 -2133

Applicant Contact lisa dimmick
Correspondent
NUCLETRON CORPORATION
8671 robert fulton dr.
columbia, 
MD 
21046 -2133

Correspodent Contact lisa dimmick
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 03/31/2008
Decision Date 04/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No