Device Classification Name |
system, applicator, radionuclide, remote-controlled
|
510(k) Number |
K040704 |
Device Name |
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR |
Applicant |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
521 HOMESTEAD AVE. |
MOUNT VERNON,
NY
10550
|
|
Applicant Contact |
FELIX MICK |
Correspondent |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
521 HOMESTEAD AVE. |
MOUNT VERNON,
NY
10550
|
|
Correspondent Contact |
FELIX MICK |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 03/18/2004 |
Decision Date | 06/18/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|