510(k) K974320 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
| Applicant | Cryogen, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 3, 1998 |
| Received | Nov 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974320
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.