Device Classification Name |
system, therapeutic, x-ray
|
510(k) Number |
K051055 |
Device Name |
INTRABEAM SYSTEM |
Applicant |
CARL ZEISS SURGICAL GMBH |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
CARL ZEISS SURGICAL GMBH |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 892.5900
|
Classification Product Code |
|
Date Received | 04/26/2005 |
Decision Date | 05/23/2005 |
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
|
|
|