510(k) K962649 ยท MTC Indicator, Chemical, Enzymatic, Sterilization Process
SPORTROL RAPID STERILITY INDICATOR
| Applicant | North American Science Assoc., Inc., Northwood OH, US |
| Decision | Substantially Equivalent, Sep 26, 1997 |
| Received | Jul 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962649
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.