I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K023242
Device Name I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
Original Applicant
IMPLANT SCIENCES CORP.
107 audubon road, #5
wakefield, 
MA 
01880 -1246

Original Contact jeffrey gibbs
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 09/30/2002
Decision Date 12/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No