The following data is part of a premarket notification filed by Ovamed Corp. with the FDA for Ovamed Fallopian Ostial Access Catheter.
| Device ID | K931167 |
| 510k Number | K931167 |
| Device Name: | OVAMED FALLOPIAN OSTIAL ACCESS CATHETER |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale, CA 94086 |
| Contact | Christine Decaria |
| Correspondent | Christine Decaria OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale, CA 94086 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1995-06-22 |