OPTIDOS


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K010705
Device Name OPTIDOS
Original Applicant
PTW-NEW YORK CORP.
201 park ave.
hicksville, 
NY 
11801

Original Contact stephen r szeglin
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 03/09/2001
Decision Date 03/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No