510(k) K920581 ยท ILO Pack, Hot Or Cold, Water Circulating
POLAR PAD (STERILE)
| Applicant | Breg, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Mar 20, 1992 |
| Received | Feb 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2013 | Breg Inc BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect. Terminated |
ILO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.