510(k) K100909 ยท JOW Sleeve, Limb, Compressible
REPROCESSED COMPRESSION SLEEVES
| Applicant | Ascent Healthcare Solutions, Phoenix AZ, US |
| Decision | Substantially Equivalent, Jul 23, 2010 |
| Received | Apr 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100909
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2023 | Stryker Sustainability Solutions REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile Open, Classified |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.