ALTON PT STEPPER


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K024183
Device Name ALTON PT STEPPER
Original Applicant
ALTON DESIGN, LLC
2655 n. ocean dr.
suite 403
singer island, 
FL 
33404

Original Contact greg wiita
Regulation Number 892.5730
Classification Product Code
KXK  
Subsequent Product Code
ITX  
Date Received 12/19/2002
Decision Date 03/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No