| Device Classification Name |
Forceps, Surgical, Gynecological
|
| 510(k) Number |
K890386 |
| Device Name |
PLACENTA AND OVUM FORCEPS |
| Applicant |
| Kinetic Medical Products |
| 4934 Peach St. |
|
Erie,
PA
16509
|
|
| Applicant Contact |
JAMES I LAUGHNER |
| Correspondent |
| Kinetic Medical Products |
| 4934 Peach St. |
|
Erie,
PA
16509
|
|
| Correspondent Contact |
JAMES I LAUGHNER |
| Regulation Number | 884.4530 |
| Classification Product Code |
|
| Date Received | 01/23/1989 |
| Decision Date | 02/13/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|