510(k) K141693 · FRG Wrap, Sterilization
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Dec 19, 2014 |
| Received | Jun 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2015 | Advanced Sterilization Products Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 Terminated |
FRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.