510(k) K811833 ยท KOE Dilator, Urethral
VNACE FASCIAL DILATOR SET
| Applicant | Vance Products, Inc. MD, US |
| Decision | Substantially Equivalent, Jul 10, 1981 |
| Received | Jun 30, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811833
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2019 | Cook Inc. Urethral Dilator Set, Global Product No. G14185 Terminated |
KOE | None listed |
| Sep 24, 2005 | Cook Urological, Inc. Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710. Terminated |
KOE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.