Device Classification Name |
system, applicator, radionuclide, remote-controlled
|
510(k) Number |
K891131 |
Device Name |
GAMMAMED 12I |
Applicant |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
P.O. BOX 99 |
BRONX,
NY
10465
|
|
Applicant Contact |
FELIX W MICK |
Correspondent |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
P.O. BOX 99 |
BRONX,
NY
10465
|
|
Correspondent Contact |
FELIX W MICK |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 03/03/1989 |
Decision Date | 08/07/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|