510(k) K103321 ยท FRC Indicator, Biological Sterilization Process
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
| Applicant | Dana Products, Inc., South Barrington IL, US |
| Decision | Substantially Equivalent, Feb 16, 2011 |
| Received | Nov 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103321
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.