SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K021311
Device Name SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
Original Applicant
CP MEDICAL
836 n.e. 24th ave.
portland, 
OR 
97232

Original Contact mary ann greenawalt
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 04/25/2002
Decision Date 07/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No