CP SLEEVE AND RIVER SLEEVE

Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K034062
Device Name CP SLEEVE AND RIVER SLEEVE
Applicant
CP MEDICAL
836 n.e. 24th ave.
portland, 
OR 
97232

Applicant Contact mary ann greenawalt
Correspondent
CP MEDICAL
836 n.e. 24th ave.
portland, 
OR 
97232

Correspodent Contact mary ann greenawalt
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 12/31/2003
Decision Date 01/30/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No