Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K071405 |
Device Name |
PROBE HOLDER SYSTEM |
Applicant |
INTUITIVE SURGICAL, INC. |
950 KIFER RD. |
SUNNYVALE,
CA
94086 -5206
|
|
Applicant Contact |
MICHAEL H YRAMATEGUI |
Correspondent |
INTUITIVE SURGICAL, INC. |
950 KIFER RD. |
SUNNYVALE,
CA
94086 -5206
|
|
Correspondent Contact |
MICHAEL H YRAMATEGUI |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/21/2007 |
Decision Date | 10/09/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|