510(k) K961855 ยท ILO Pack, Hot Or Cold, Water Circulating
POLAR CARE (MODEL 500/50000)
| Applicant | Breg, Inc., Vista CA, US |
| Decision | Substantially Equivalent, Aug 9, 1996 |
| Received | May 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961855
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.