510(k) K101528 ยท JOJ Indicator, Physical/Chemical Sterilization Process
3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
| Applicant | 3M Company, St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 1, 2010 |
| Received | Jun 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248.
b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348. Open, Classified |
JOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.