Device Classification Name |
source, brachytherapy, radionuclide
|
510(k) Number |
K093663 |
Device Name |
RADIONUCLIDE BRACHYTHERAPY SOURCE |
Applicant |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Applicant Contact |
JULIE BASSETT |
Correspondent |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
JULIE BASSETT |
Regulation Number | 892.5730
|
Classification Product Code |
|
Date Received | 11/25/2009 |
Decision Date | 12/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|