The following data is part of a premarket notification filed by Phoenix Bioengineering, Inc. with the FDA for Phoenix Burr Hole Button, Burr 1.
| Device ID | K913490 |
| 510k Number | K913490 |
| Device Name: | PHOENIX BURR HOLE BUTTON, BURR 1 |
| Classification | Cover, Burr Hole |
| Applicant | PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport, PA 19405 |
| Contact | Horace J Wilmer |
| Correspondent | Horace J Wilmer PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport, PA 19405 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-06 |
| Decision Date | 1992-01-13 |