The following data is part of a premarket notification filed by Phoenix Biomedical Corp. with the FDA for Phoenix Crx Valve.
| Device ID | K960435 |
| 510k Number | K960435 |
| Device Name: | PHOENIX CRX VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. P.O. BOX 80390 Valley Forge, PA 19484 |
| Contact | Horace J Wilmer |
| Correspondent | Horace J Wilmer PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. P.O. BOX 80390 Valley Forge, PA 19484 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-31 |
| Decision Date | 1996-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760124134148 | K960435 | 000 |
| 03760124134131 | K960435 | 000 |
| 03760124134124 | K960435 | 000 |
| 03760124134117 | K960435 | 000 |
| 03760124134094 | K960435 | 000 |