Device Classification Name |
system, applicator, radionuclide, remote-controlled
|
510(k) Number |
K122840 |
Device Name |
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 |
Applicant |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
521 HOMESTEAD AVE. |
MOUNT VERNON,
NY
10550
|
|
Applicant Contact |
CHUCK SMITH |
Correspondent |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
521 HOMESTEAD AVE. |
MOUNT VERNON,
NY
10550
|
|
Correspondent Contact |
CHUCK SMITH |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 09/17/2012 |
Decision Date | 12/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|