PHARMASEED, MODEL BT-125-1


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K992008
Device Name PHARMASEED, MODEL BT-125-1
Applicant
SYNCOR PHARMACEUTICALS, INC.
1313 washington ave.
golden, 
CO 
80401

Applicant Contact gary gilmore
Correspondent
SYNCOR PHARMACEUTICALS, INC.
1313 washington ave.
golden, 
CO 
80401

Correspodent Contact gary gilmore
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 06/15/1999
Decision Date 12/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No