510(k) K070402 ยท ILO Pack, Hot Or Cold, Water Circulating
MODIFICATION TO POLAR CARE 500
| Applicant | Breg, Inc., Vista CA, US |
| Decision | Substantially Equivalent, Mar 29, 2007 |
| Received | Feb 12, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070402
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.