Device Classification Name |
cannula, suction, uterine
|
510(k) Number |
K093508 |
Device Name |
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) |
Applicant |
WOMANCARE GLOBAL |
300 MARKET ST. SUITE 134 |
CHAPEL HILL,
NC
27516
|
|
Applicant Contact |
Susanne Parks |
Correspondent |
WOMANCARE GLOBAL |
300 MARKET ST. SUITE 134 |
CHAPEL HILL,
NC
27516
|
|
Correspondent Contact |
Susanne Parks |
Regulation Number | 884.5070
|
Classification Product Code |
|
Date Received | 11/12/2009 |
Decision Date | 03/04/2010 |
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
|
|
|