510(k) K013228 ยท JOJ Indicator, Physical/Chemical Sterilization Process
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
| Applicant | Minnesota Mining and Mfg. Co., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 18, 2002 |
| Received | Sep 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2006 | 3M Company / Medical Division 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant. Terminated |
JOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.