510(k) K830332 ยท GZT Retractor, Self-Retaining, For Neurosurgery
BUDDE-HALO RETRACTOR
| Applicant | Ohio Medical Instrument Co., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 2, 1983 |
| Received | Feb 1, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830332
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2003 | Ohio Medical Instrument Co Inc Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part Terminated |
GZT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.