The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Ally Uterine Positioning System.
| Device ID | K153092 |
| 510k Number | K153092 |
| Device Name: | Ally Uterine Positioning System |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Contact | Roaida Johnson |
| Correspondent | Roaida Johnson CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALLY UTERINE POSITIONING SYSTEM 86423349 4882736 Live/Registered |
CooperSurgical, Inc. 2014-10-14 |