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FDA 510(k) Applications for Medical Device Product Code "HDR"
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| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K222969 | Rosesta Medical BV | FERTI-LILY Conception Cup | 06/23/2023 |
| K242031 | StepOne Fertility Ltd (t/a BΘa Fertility) | BΘa Applicator (BAP-GB-01) | 04/02/2025 |
| K993953 | VEOS LTD. | OVES CERVICAL CAP | 03/21/2000 |