510(k) K111377 ยท MLR Sterilizer, Chemical
STERRAD(R) 100NX STERILIZER DUO CYCLE
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Sep 13, 2012 |
| Received | May 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111377
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 100NX, Product Code 10144
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive re Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.