510(k) K010338 ยท DWJ System, Thermal Regulating
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Mar 7, 2001 |
| Received | Feb 5, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2005 | MEDIVANCE INC. Arctic Sun Temperature Management System Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.