Device Classification Name |
system, applicator, radionuclide, remote-controlled
|
510(k) Number |
K041715 |
Device Name |
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 |
Applicant |
NUCLETRON CORP. |
8671 ROBERT FULTON DRIVE |
COLUMBIA,
MD
21046 -2133
|
|
Applicant Contact |
LISA DIMMICK |
Correspondent |
NUCLETRON CORP. |
8671 ROBERT FULTON DRIVE |
COLUMBIA,
MD
21046 -2133
|
|
Correspondent Contact |
LISA DIMMICK |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 06/23/2004 |
Decision Date | 03/24/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|