Device Classification Name |
Source, Brachytherapy, Radionuclide
|
510(k) Number |
K150895 |
Device Name |
SPEC Model M16 |
Applicant |
Source Production and Equipment Co.,Inc. |
113 Teal Street |
St. Rose,
LA
70087
|
|
Applicant Contact |
Kelly Richardt |
Correspondent |
Source Production and Equipment Co.,Inc. |
113 Teal Street |
St. Rose,
LA
70087
|
|
Correspondent Contact |
Kelly Richardt |
Regulation Number | 892.5730
|
Classification Product Code |
|
Date Received | 04/02/2015 |
Decision Date | 06/19/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|