K961859 is an FDA 510(k) clearance for the NOVUS STANDARD AND PEDIATRIC VALVES. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Integra Neurocare, LLC (Pleasant Prairie, US). The FDA issued a Cleared decision on December 16, 1996, 216 days after receiving the submission on May 14, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K961859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1996 |
| Decision Date | December 16, 1996 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | JXG — Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |