510(k) K061316 ยท LWH Counter, Sponge, Surgical
MEDLINE SURGICAL SPONGE SCANNER
| Applicant | Medline Industries, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Nov 2, 2006 |
| Received | May 11, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061316
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Medline Industries Inc Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Manufactured for: Medline Industries, Inc., Mundelein, IL 6 Terminated |
GDY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.