510(k) K854095 ยท LRO General Surgery Tray
BIOPSY TRAY I & II
| Applicant | North Coast Medi-Tek, Eastlake OH, US |
| Decision | Unknown, Nov 25, 1985 |
| Received | Oct 7, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2011 | North Coast Medi-Tek Inc Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case.
Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used i Terminated |
LOR | None listed |
| Sep 21, 2005 | North Coast Medi-Tek Inc SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case. Terminated |
LRO | None listed |
| Sep 8, 2005 | North Coast Medi-Tek Inc E-Z-EM brand, Basic biopsy tray, catalog no. 4125. Terminated |
LRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.