510(k) K964047 ยท GEH Unit, Cryosurgical, Accessories
CRYOSIL SILICONE GEL SHEETING
| Applicant | Biodermis Corp., Las Vegas NV, US |
| Decision | Substantially Equivalent, Mar 19, 1997 |
| Received | Oct 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964047
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.