510(k) K081323 ยท FCG Biopsy Needle
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
| Applicant | B-K Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Jul 22, 2008 |
| Received | May 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081323
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.