510(k) K012068 ยท MQE Needle, Assisted Reproduction
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
| Applicant | Sims Portex , Ltd., Hythe, Kent, GB |
| Decision | Substantially Equivalent, Aug 3, 2001 |
| Received | Jul 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2008 | Irvine Scientific Sales Co Inc Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750.
Retrieval of Oocytes. Terminated |
MQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.