510(k) K081057 ยท KNW Instrument, Biopsy
INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
| Applicant | Intact Medical Corporation, Natick MA, US |
| Decision | Substantially Equivalent, Jun 17, 2008 |
| Received | Apr 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081057
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.