Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K961400 |
Device Name |
RFA-300, LDA UTILITY |
Applicant |
SCANDITRONIX MEDICAL AB |
33 JACKSONVILLE RD. |
BUILDING 1 |
TOWACO,
NJ
07082
|
|
Applicant Contact |
ROBERT P MORRISON |
Correspondent |
SCANDITRONIX MEDICAL AB |
33 JACKSONVILLE RD. |
BUILDING 1 |
TOWACO,
NJ
07082
|
|
Correspondent Contact |
ROBERT P MORRISON |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 04/11/1996 |
Decision Date | 01/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|