510(k) K083650 ยท JOJ Indicator, Physical/Chemical Sterilization Process
EMU-GRAPH 4 EMULATOR, MODEL CI 144
| Applicant | Steritec Products, Inc., Castle Rock CO, US |
| Decision | Substantially Equivalent, Mar 5, 2009 |
| Received | Dec 9, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2010 | Steritec Products Mfc. Co., Inc. Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238. Terminated |
JOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.