Device Classification Name |
Source, Brachytherapy, Radionuclide
|
510(k) Number |
K122764 |
Device Name |
RAPID STRAND RX |
Applicant |
MEDI-PHYSICS, INC. |
3350 NORTH RIDGE AVE. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
DAVID RISLEY |
Correspondent |
MEDI-PHYSICS, INC. |
3350 NORTH RIDGE AVE. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
DAVID RISLEY |
Regulation Number | 892.5730
|
Classification Product Code |
|
Date Received | 09/10/2012 |
Decision Date | 12/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|