RE-ENTRANT CHAMBER, MODEL 1008 OR 44D


the company

Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K002446
Device Name RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
Original Applicant
SUN NUCLEAR CORP.
425-a pineda court
melbourne, 
FL 
32940

Original Contact thomas l powers
Regulation Number 892.5730
Classification Product Code
KXK  
Subsequent Product Code
JAQ  
Date Received 08/09/2000
Decision Date 10/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No