510(k) K993435 ยท KNW Instrument, Biopsy
MANUAL BONE MARROW BIOPSY DEVICE
| Applicant | Promex, Inc., Franklin IN, US |
| Decision | Substantially Equivalent, Dec 6, 1999 |
| Received | Oct 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2008 | Theken Spine LLC Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.