510(k) K961405 ยท JOW Sleeve, Limb, Compressible
ALBA HEALTH PAS WRAP SYSTEM
| Applicant | Alba-Waldensian, Inc., Valdese NC, US |
| Decision | Substantially Equivalent, Dec 26, 1996 |
| Received | Apr 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961405
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2011 | Albahealth LLC Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC.
Prevention of DVT. Terminated |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.