Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K013491 |
Device Name |
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 |
Applicant |
A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE |
ALPHARETTA,
GA
30004 -3383
|
|
Applicant Contact |
JAY MANSOUR |
Correspondent |
A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE |
ALPHARETTA,
GA
30004 -3383
|
|
Correspondent Contact |
JAY MANSOUR |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 10/22/2001 |
Decision Date | 11/19/2001 |
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
|
|
|