510(k) K811233 ยท KPE Container, I.V.
I.V. PLASTIC BAG
| Applicant | Medi-Plast Intl., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 17, 1981 |
| Received | May 4, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2024 | Microtek Medical Inc. C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). Open, Classified |
KPE | None listed |
| Aug 16, 2024 | Microtek Medical Inc. Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). Open, Classified |
KPE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.