VALENCIA SKIN APPLICATOR SET, MODEL: 189.701


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K073107
Device Name VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
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 11/02/2007
Decision Date 12/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No