The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Evds, Evmds, Lds & Ivmcs Central Nervous Sys Fluid.
| Device ID | K855058 |
| 510k Number | K855058 |
| Device Name: | EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Contact | David Kornhauser |
| Correspondent | David Kornhauser CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-18 |
| Decision Date | 1986-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780035596 | K855058 | 000 |