The following data is part of a premarket notification filed by Phoenix Biomedical Corp. with the FDA for Phoenix Universal Shunt System.
| Device ID | K024101 |
| 510k Number | K024101 |
| Device Name: | PHOENIX UNIVERSAL SHUNT SYSTEM |
| 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 | 2002-12-12 |
| Decision Date | 2003-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760124135374 | K024101 | 000 |
| 03760124134162 | K024101 | 000 |
| 03760124134179 | K024101 | 000 |
| 03760124135220 | K024101 | 000 |
| 03760124135237 | K024101 | 000 |
| 03760124135244 | K024101 | 000 |
| 03760124135251 | K024101 | 000 |
| 03760124135282 | K024101 | 000 |
| 03760124135312 | K024101 | 000 |
| 03760124135343 | K024101 | 000 |
| 03760124134155 | K024101 | 000 |