Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K022503 |
Device Name |
UTERINE INJECTOR |
Applicant |
THOMAS MEDICAL, INC. |
4100-C NINE MCFARLAND DR. |
ALPHARETTA,
GA
30004
|
|
Applicant Contact |
THOMAS J ZINNANTI |
Correspondent |
THOMAS MEDICAL, INC. |
4100-C NINE MCFARLAND DR. |
ALPHARETTA,
GA
30004
|
|
Correspondent Contact |
THOMAS J ZINNANTI |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/29/2002 |
Decision Date | 10/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|