The following data is part of a premarket notification filed by Phoenix Biomedical Corp. with the FDA for Crx World Shunt.
| Device ID | K990256 |
| 510k Number | K990256 |
| Device Name: | CRX WORLD SHUNT |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. Norristown, PA 19403 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. Norristown, PA 19403 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-27 |
| Decision Date | 1999-04-01 |