510(k) K024293 ยท JOJ Indicator, Physical/Chemical Sterilization Process
BOWIE-DICK MINI PAK, MODEL BD 115
| Applicant | Steritec Products, Inc., Castle Rock CO, US |
| Decision | Substantially Equivalent, Aug 11, 2003 |
| Received | Dec 24, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K024293
| 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.