Device Classification Name |
source, brachytherapy, radionuclide
|
510(k) Number |
K142701 |
Device Name |
SMD Sr90-1 Radionuclide Brachytherapy Source |
Applicant |
Salutaris Medical Devices, Inc. |
4330 N Campbell Ave, Suite 250 |
Tucson,
AZ
85718
|
|
Applicant Contact |
Laurence Marsteller |
Correspondent |
Salutaris Medical Devices, Inc. |
4330 N Campbell Ave, Suite 250 |
Tucson,
AZ
85718
|
|
Correspondent Contact |
Laurence Marsteller |
Regulation Number | 892.5730
|
Classification Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 12/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|