The following data is part of a premarket notification filed by Fertility Technology Resources, Inc. with the FDA for Embryo Glide Embryo Transfer Catheter, Embryo Glide Style For Embryo Transfer Catheter.
| Device ID | K992307 |
| 510k Number | K992307 |
| Device Name: | EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER |
| Classification | Catheter, Assisted Reproduction |
| Applicant | FERTILITY TECHNOLOGY RESOURCES, INC. 4343 SHALLOWFORD RD. SUITE D-4 Marietta, GA 30062 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-09 |
| Decision Date | 1999-09-13 |
| Summary: | summary |