Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K891451 |
Device Name |
OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE |
Applicant |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
JOSEPH R WILLIAMS |
Correspondent |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
JOSEPH R WILLIAMS |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 03/15/1989 |
Decision Date | 10/02/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|