510(k) K853368 ยท GYK Instrument, Shunt System Implantation
H-H SHUNT INTRODUCER
| Applicant | Holter-Hausner Intl., Bridgeport PA, US |
| Decision | Substantially Equivalent, Sep 6, 1985 |
| Received | Aug 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853368
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.