Device Classification Name |
system, applicator, radionuclide, remote-controlled
|
510(k) Number |
K150979 |
Device Name |
CT/MR Compatible M.A.C. Interstitial GYN Template |
Applicant |
Mick Radio-Nuclear Instruments, Inc. |
521 Homestead Avenue |
Mount Vermon,
NY
10550
|
|
Applicant Contact |
Chuck Smith |
Correspondent |
Mick Radio-Nuclear Instruments, Inc. |
521 Homestead Avenue |
Mount Vernon,
NY
10550
|
|
Correspondent Contact |
Chuck Smith |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 04/13/2015 |
Decision Date | 05/31/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|