The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Majoli Uterine Manipulator/injector.
| Device ID | K911887 |
| 510k Number | K911887 |
| Device Name: | MAJOLI UTERINE MANIPULATOR/INJECTOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-29 |
| Decision Date | 1991-07-26 |