ISOSEEDS I-125


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K021343
Device Name ISOSEEDS I-125
Original Applicant
BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH
robert-rossle str 10
berlin, 

DE

d-131125

Original Contact sven langer
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 04/29/2002
Decision Date 05/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No