510(k) K971514 ยท LYY Latex Patient Examination Glove
REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
| Applicant | London International Group, Inc., Dotham AL, US |
| Decision | Substantially Equivalent, Oct 29, 1997 |
| Received | Apr 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971514
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.