510(k) K012821 ยท HRN Unit, Cryophthalmic, Ac-Powered
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
| Applicant | Dutch Ophthalmic USA, Inc., Kingston NH, US |
| Decision | Substantially Equivalent, Oct 22, 2001 |
| Received | Aug 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012821
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.