510(k) K964117 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
| Applicant | Kawasumi Laboratories Co., Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Mar 14, 1997 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964117
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.