510(k) Premarket Notification Database
Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number | K911887 |
Device Name | MAJOLI UTERINE MANIPULATOR/INJECTOR |
Applicant |
COOK OB/GYN
|
1100 west morgan st. |
p.o. box 271 |
spencer,
IN
47460 |
|
Contact | michelle young |
Classification Product Code |
|
Date Received | 04/29/1991 |
Decision Date | 07/26/1991 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Statement/Summary/Purged Status |
Statement/purged 510(k)
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|