The following data is part of a premarket notification filed by Phoenix Biomedical Corp. with the FDA for Crx Diamond Valve.
| Device ID | K974096 |
| 510k Number | K974096 |
| Device Name: | CRX DIAMOND VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. Norristown, PA 19403 |
| Contact | David Kunin |
| Correspondent | David Kunin PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. Norristown, PA 19403 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-30 |
| Decision Date | 1998-12-08 |