The following data is part of a premarket notification filed by Marina Medical Instruments, Inc. with the FDA for Uterine Manipulator Injector Cannula, Model R57-450.
| Device ID | K010296 |
| 510k Number | K010296 |
| Device Name: | UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | MARINA MEDICAL INSTRUMENTS, INC. 2761 N 29TH AVE. Hollywood, FL 33020 |
| Contact | Jihad (jay) Mansour |
| Correspondent | Jihad (jay) Mansour MARINA MEDICAL INSTRUMENTS, INC. 2761 N 29TH AVE. Hollywood, FL 33020 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-31 |
| Decision Date | 2001-04-11 |