510(k) K100367 ยท MQL Media, Reproductive
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229
| Applicant | Origio A/S, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 27, 2010 |
| Received | Feb 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2020 | CooperSurgical, Inc. MediCult Vitrification Cooling Media, Model Number 12284001F Terminated |
MQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.