510(k) K080645 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
STD MED PRIMO PORT POLY
| Applicant | Std Med, Inc., Ayer MA, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Mar 6, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080645
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.