The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for Bernstein(tm) Uterine Manipulator.
| Device ID | K932394 |
| 510k Number | K932394 |
| Device Name: | BERNSTEIN(TM) UTERINE MANIPULATOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Contact | David C Steffin |
| Correspondent | David C Steffin GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-18 |
| Decision Date | 1995-01-26 |