RADIOMED SOURCE


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K001070
Device Name RADIOMED SOURCE
Original Applicant
RADIOMED CORP.
9 linnell circle
billerica, 
MA 
01821

Original Contact john schwamb
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 04/03/2000
Decision Date 10/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No