The following data is part of a premarket notification filed by Hamilton Thorne Incorporated with the FDA for Gm501 Spermair And Gm501 Spermactive.
| Device ID | K192644 |
| 510k Number | K192644 |
| Device Name: | GM501 SpermAir And GM501 SpermActive |
| Classification | Media, Reproductive |
| Applicant | Hamilton Thorne Incorporated 100 Cummings Center, Suite 465E Beverly, MA 01915 |
| Contact | Donald Fournier |
| Correspondent | Donald Fournier Hamilton Thorne Incorporated 100 Cummings Center, Suite 465E Beverly, MA 01915 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-24 |
| Decision Date | 2020-04-23 |