The following data is part of a premarket notification filed by Genx Intl., Inc. with the FDA for Genxcatheter.
| Device ID | K963031 |
| 510k Number | K963031 |
| Device Name: | GENXCATHETER |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | GENX INTL., INC. 339 BARTLETT DR. Madison, CT 06443 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi GENX INTL., INC. 339 BARTLETT DR. Madison, CT 06443 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1996-10-21 |