510(k) K171398 ยท GEH Unit, Cryosurgical, Accessories
Dermal Cooling System
| Applicant | R2 Dermatology ,Inc, San Ramon CA, US |
| Decision | Substantially Equivalent, Jul 6, 2017 |
| Received | May 12, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171398
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.