The following data is part of a premarket notification filed by Crossbay Medical, Inc. with the FDA for Sonoflow Sonohysterography And Sonohysterosalpingography Device.
| Device ID | K142545 |
| 510k Number | K142545 |
| Device Name: | SonoFlow Sonohysterography And Sonohysterosalpingography Device |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CrossBay Medical, Inc. 793 Sandoval Way Hayward, CA 94544 |
| Contact | Piush Vidyarthi |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-10 |
| Decision Date | 2015-03-20 |
| Summary: | summary |