The following data is part of a premarket notification filed by Biomedics with the FDA for The Bioplate Shunt Connector.
| Device ID | K984583 |
| 510k Number | K984583 |
| Device Name: | THE BIOPLATE SHUNT CONNECTOR |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | BIOMEDICS 536 RIMPAU BLVD. Los Angeles, CA 90020 |
| Contact | Eric V Hohenstein |
| Correspondent | Eric V Hohenstein BIOMEDICS 536 RIMPAU BLVD. Los Angeles, CA 90020 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-24 |
| Decision Date | 1999-03-15 |