510(k) K940425 ยท MAV Syringe, Balloon Inflation
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
| Applicant | Imagyn Medical, Inc., Laguna Niguel CA, US |
| Decision | Substantially Equivalent, Aug 1, 1994 |
| Received | Jan 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940425
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.