Device Classification Name |
Forceps, Biopsy, Gynecological
|
510(k) Number |
K902049 |
Device Name |
CROAK OVARIAN BIOPSY FORCEP |
Applicant |
GYNESCOPE CORP. |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
SCOTT C MARLOW |
Correspondent |
GYNESCOPE CORP. |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
SCOTT C MARLOW |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/07/1990 |
Decision Date | 06/07/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|