510(k) K982797 ยท DYB Introducer, Catheter
BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
| Applicant | Luther Medical Products, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, Nov 30, 1998 |
| Received | Aug 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982797
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.