VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K080934
Device Name VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
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 04/02/2008
Decision Date 05/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No