The following data is part of a premarket notification filed by Phoenix Biomedical Corp. with the FDA for Acura Elite Gravity Compensating Reservoir.
| Device ID | K030468 |
| 510k Number | K030468 |
| Device Name: | ACURA ELITE GRAVITY COMPENSATING RESERVOIR |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMISTEAD AVE. P.O. BOX 80390 Valley Forge, PA 19484 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMISTEAD 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 | 2003-02-12 |
| Decision Date | 2003-10-15 |