The following data is part of a premarket notification filed by Cooper Surgical, Inc. with the FDA for Ally Ups.
| Device ID | K141523 |
| 510k Number | K141523 |
| Device Name: | ALLY UPS |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | COOPER SURGICAL, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Tim M Lohnes |
| Correspondent | Tim M Lohnes COOPER SURGICAL, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-09 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937019951 | K141523 | 000 |
| 00888937015836 | K141523 | 000 |
| 20888937015816 | K141523 | 000 |