Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K032835 |
Device Name |
H/S CATHETER SET |
Applicant |
CATHETER RESEARCH, INC. |
6131 WEST 80TH ST. |
INDIANAPOLIS,
IN
46278
|
|
Applicant Contact |
JOHN A STEEN |
Correspondent |
CATHETER RESEARCH, INC. |
6131 WEST 80TH ST. |
INDIANAPOLIS,
IN
46278
|
|
Correspondent Contact |
JOHN A STEEN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/11/2003 |
Decision Date | 12/11/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|