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 |