510(k) K011512 ยท HDY Dilator, Cervical, Hygroscopic-Laminaria
MMODIFICATION TO LAMINARIA
| Applicant | A & A Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jul 9, 2001 |
| Received | May 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011512
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.