Device Classification Name |
System, Applicator, Radionuclide, Remote-Controlled
|
510(k) Number |
K983436 |
Device Name |
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM |
Applicant |
GAMMAMED USA |
2464 EAST STADIUM WAY |
ANN ARBOR,
MI
48104
|
|
Applicant Contact |
JOHN J MUNRO III |
Correspondent |
GAMMAMED USA |
2464 EAST STADIUM WAY |
ANN ARBOR,
MI
48104
|
|
Correspondent Contact |
JOHN J MUNRO III |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 09/29/1998 |
Decision Date | 10/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|