The following data is part of a premarket notification filed by Bryan Corp. with the FDA for Biotrace, Model 1730.
| Device ID | K002063 |
| 510k Number | K002063 |
| Device Name: | BIOTRACE, MODEL 1730 |
| Classification | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
| Applicant | BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
| Contact | Rose S Logsdon |
| Correspondent | Rose S Logsdon BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
| Product Code | MYU |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-07 |
| Decision Date | 2000-08-10 |