The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Margolin Hsg Cannula, Goldstein Sonohysterography Catheter.
| Device ID | K180300 |
| 510k Number | K180300 |
| Device Name: | Margolin HSG Cannula, Goldstein Sonohysterography Catheter |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Naomi Funkhouser |
| Correspondent | Naomi Funkhouser Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-02 |
| Decision Date | 2018-10-26 |
| Summary: | summary |