510(k) K161480 ยท GEH Unit, Cryosurgical, Accessories
R2 Dermal Cooling System
| Applicant | R2 Dermatology, San Ramon CA, US |
| Decision | Substantially Equivalent, Oct 5, 2016 |
| Received | May 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161480
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.