510(k) K080558 ยท FRG Wrap, Sterilization
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
| Applicant | Case Medical, Inc., Ridgefield NJ, US |
| Decision | Substantially Equivalent, Dec 5, 2008 |
| Received | Feb 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080558
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2013 | Advanced Sterilization Products STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: Terminated |
FRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.