The following data is part of a premarket notification filed by Integra Neurocare Llc. with the FDA for Novus Standard And Pediatric Valves.
| Device ID | K961859 |
| 510k Number | K961859 |
| Device Name: | NOVUS STANDARD AND PEDIATRIC VALVES |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie, WI 53150 -0390 |
| Contact | Terry N Layton |
| Correspondent | Terry N Layton INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie, WI 53150 -0390 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1996-12-16 |