Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K903146 |
Device Name |
HYSTEROSCOPY SHEATH SET |
Applicant |
COOK, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Applicant Contact |
MICHELLE YOUNG |
Correspondent |
COOK, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
MICHELLE YOUNG |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 07/18/1990 |
Decision Date | 10/12/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|