510(k) K190590 ยท MQE Needle, Assisted Reproduction
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
| Applicant | Allwin Medical Devices, Inc., Anaheim CA, US |
| Decision | Substantially Equivalent, Nov 25, 2019 |
| Received | Mar 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190590
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.