510(k) K964238 ยท JOW Sleeve, Limb, Compressible
AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS
| Applicant | Aircast, Inc., Summit NJ, US |
| Decision | Substantially Equivalent, Sep 8, 1997 |
| Received | Oct 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2019 | DJO, LLC Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC. Open, Classified |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.