K874630 is an FDA 510(k) clearance for the RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS. This device is classified as a Instrument, Surgical, Non-powered (Class I - General Controls, product code HAO).
Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on December 23, 1987, 43 days after receiving the submission on November 10, 1987.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4535.
| 510(k) Number | K874630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1987 |
| Decision Date | December 23, 1987 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HAO — Instrument, Surgical, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4535 |