510(k) K113660 ยท LKX Device, Thermal, Hemorrhoids
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
| Applicant | Cryotherapy Products, Inc., Terrace Davie FL, US |
| Decision | Substantially Equivalent, May 3, 2012 |
| Received | Dec 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113660
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.