SELECT SEED I-125


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K002429
Device Name SELECT SEED I-125
Original Applicant
NUCLETRON CORP.
7080 columbia gateway dr.
columbia, 
MD 
21046

Original Contact robert applebaum
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 08/08/2000
Decision Date 02/02/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No