510(k) K981625 ยท MLR Sterilizer, Chemical
STERRAD 50 STERILIZER
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Jan 11, 1999 |
| Received | May 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2009 | Advanced Sterilization Products Sterrad 50 Sterilizer, Product Code 10050.
Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Jun 15, 2009 | Advanced Sterilization Products STERRAD 50 Sterilization System Product Code 10050
The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devi Terminated |
FLF | None listed |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 50 Sterilization System, Product Code 10050
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Feb 8, 2008 | Advanced Sterilization Products STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA Terminated |
MLR | None listed |
| Feb 7, 2008 | Advanced Sterilization Products STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.