Device Classification Name |
system, radiation therapy, radionuclide
|
510(k) Number |
K092083 |
Device Name |
EXTEND FRAME SYSTEM, MODEL 1009633 |
Applicant |
ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 |
P.O.BOX 7593 |
STOCKHOLM,
SE
S-103 93
|
|
Applicant Contact |
ABDERS SKOGLUND |
Correspondent |
ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 |
P.O.BOX 7593 |
STOCKHOLM,
SE
S-103 93
|
|
Correspondent Contact |
ABDERS SKOGLUND |
Regulation Number | 892.5750
|
Classification Product Code |
|
Date Received | 07/09/2009 |
Decision Date | 09/22/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|