Device Classification Name |
tenaculum, uterine
|
510(k) Number |
K894891 |
Device Name |
IRRIGATOR STAND |
Applicant |
COMMERCIAL PRODUCTS & ENGINEERING CO. |
5001 KENDRICK, S.E. |
GRAND RAPIDS,
MI
49512
|
|
Applicant Contact |
JOHN LAMONACO |
Correspondent |
COMMERCIAL PRODUCTS & ENGINEERING CO. |
5001 KENDRICK, S.E. |
GRAND RAPIDS,
MI
49512
|
|
Correspondent Contact |
JOHN LAMONACO |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/01/1989 |
Decision Date | 08/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|