510(k) K152596 · KNW Instrument, Biopsy
Intact® Gen2 System
| Applicant | Intact Medical Corporation, Framingham MA, US |
| Decision | Substantially Equivalent, Feb 15, 2016 |
| Received | Sep 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152596
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.