The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Kronner Reinforcing Stylette.
| Device ID | K932432 |
| 510k Number | K932432 |
| Device Name: | KRONNER REINFORCING STYLETTE |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Contact | Edward C Vollmer |
| Correspondent | Edward C Vollmer UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-20 |
| Decision Date | 1994-04-12 |