Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K010056 |
Device Name |
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 |
Applicant |
A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE |
ALPHARETTA,
GA
30004 -3383
|
|
Applicant Contact |
JIHAD MANSOUR |
Correspondent |
A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE |
ALPHARETTA,
GA
30004 -3383
|
|
Correspondent Contact |
JIHAD MANSOUR |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 01/08/2001 |
Decision Date | 02/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|