510(k) K982810 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
SHELHIGH NO-REACT VASCUPATCH
| Applicant | Shelhigh, Inc., Millburn NJ, US |
| Decision | Substantially Equivalent, Oct 28, 1998 |
| Received | Aug 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982810
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.