| Device Classification Name |
Forceps, Obstetrical
|
| 510(k) Number |
K851883 |
| Device Name |
SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 |
| Applicant |
| The Huxley Instrument Corp. |
| 215 Main St. |
|
Penn Yan,
NY
14527
|
|
| Applicant Contact |
REBECCA J SHAHZADA |
| Correspondent |
| The Huxley Instrument Corp. |
| 215 Main St. |
|
Penn Yan,
NY
14527
|
|
| Correspondent Contact |
REBECCA J SHAHZADA |
| Regulation Number | 884.4400 |
| Classification Product Code |
|
| Date Received | 04/29/1985 |
| Decision Date | 05/09/1985 |
| 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
|
|
|