Device Classification Name |
system, therapeutic, x-ray
|
510(k) Number |
K110590 |
Device Name |
INTRABEAM NEEDLE APPLICATOR |
Applicant |
CARL ZEISS SURGICAL GMBH |
5160 HACIENDA DRIVE |
DUBLIN,
CA
94568
|
|
Applicant Contact |
JUDITH A BRIMACOMBE, MA |
Correspondent |
CARL ZEISS SURGICAL GMBH |
5160 HACIENDA DRIVE |
DUBLIN,
CA
94568
|
|
Correspondent Contact |
JUDITH A BRIMACOMBE, MA |
Regulation Number | 892.5900
|
Classification Product Code |
|
Date Received | 03/02/2011 |
Decision Date | 04/13/2012 |
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
|
|
|