510(k) K982358 ยท GEH Unit, Cryosurgical, Accessories
HISTOFREEZER DEVICE
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Oct 2, 1998 |
| Received | Jul 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982358
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.