Device Classification Name |
tenaculum, uterine
|
510(k) Number |
K060573 |
Device Name |
BURBANK TENACULUM |
Applicant |
VASCULAR CONTROL SYSTEMS, INC |
32236-F PASEO ADELANTO |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Applicant Contact |
KATHLEEN ROBERTS |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 884.4530
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/06/2006 |
Decision Date | 04/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|