The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Godat Uterine Manipulator Injector.
| Device ID | K935023 |
| 510k Number | K935023 |
| Device Name: | GODAT UTERINE MANIPULATOR INJECTOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1995-01-04 |