510(k) K934545 ยท JXG Shunt, Central Nervous System And Components
PS MEDICAL DELTA BURR HOLE VALVE
| Applicant | Pudenz-Schulte Medical Research Corp., Goleta CA, US |
| Decision | Substantially Equivalent, Apr 28, 1994 |
| Received | Sep 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934545
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.