510(k) K090821 ยท GDW Staple, Implantable
CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L
| Applicant | Frankenman International Limited, Austin TX, US |
| Decision | Substantially Equivalent, Jun 10, 2009 |
| Received | Mar 26, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090821
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.