510(k) K970533 ยท ILO Pack, Hot Or Cold, Water Circulating
MODEL 1100 COLD THERAPY DEVICE
| Applicant | Smith & Nephew, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 15, 1997 |
| Received | Feb 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970533
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.