510(k) K072594 ยท FGA Kit, Nephroscope
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Dec 13, 2007 |
| Received | Sep 14, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072594
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.