BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K103449
Device Name BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
Applicant
RIVERPOINT MEDICAL
825 ne 25th ave.
portland, 
OR 
97232

Applicant Contact doug rowley
Correspondent
RIVERPOINT MEDICAL
825 ne 25th ave.
portland, 
OR 
97232

Correspodent Contact doug rowley
Regulation Number 892.5730
Classification Product Code
KXK  
Subsequent Product Code
IYE  
Date Received 11/23/2010
Decision Date 02/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No