The following data is part of a premarket notification filed by Blairden Precision Instruments, Inc. with the FDA for Rowden Uterine Manipulator Injector And Rumi.
| Device ID | K932115 |
| 510k Number | K932115 |
| Device Name: | ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | BLAIRDEN PRECISION INSTRUMENTS, INC. 10053 LAKEVIEW AVE. Lenexa, KS 66219 |
| Contact | Jim Rowden |
| Correspondent | Jim Rowden BLAIRDEN PRECISION INSTRUMENTS, INC. 10053 LAKEVIEW AVE. Lenexa, KS 66219 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-03 |
| Decision Date | 1994-06-24 |