510(k) K011544 ยท LYA Splint, Intranasal Septal
HADGEL, 4 GRAM/SYRINGE
| Applicant | Seikagaku Corp., Kitty Hawk NC, US |
| Decision | Substantially Equivalent, Aug 15, 2001 |
| Received | May 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011544
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.