The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Disposable Uterine Manipulator.
| Device ID | K930867 |
| 510k Number | K930867 |
| Device Name: | AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-19 |
| Decision Date | 1994-07-25 |