Device Classification Name |
system, applicator, radionuclide, remote-controlled
|
510(k) Number |
K061241 |
Device Name |
BIOLUCENT APPLICATOR, MODEL RTA-XX |
Applicant |
BIOLUCENT, INC. |
6 JOURNEY, SUITE 325 |
ALISO VIEJO,
CA
92656
|
|
Applicant Contact |
J. DAVID CAMPBELL |
Correspondent |
BIOLUCENT, INC. |
6 JOURNEY, SUITE 325 |
ALISO VIEJO,
CA
92656
|
|
Correspondent Contact |
J. DAVID CAMPBELL |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 05/03/2006 |
Decision Date | 07/28/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|