510(k) K951033 ยท IMD Pack, Hot Or Cold, Disposable
ANDELA DYNAMIC COOLING DEVICE
| Applicant | Candela Laser Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Aug 15, 1996 |
| Received | Mar 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951033
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.