The following data is part of a premarket notification filed by Etex Corp. with the FDA for Bsm- Bone Substitute Material.
| Device ID | K983009 |
| 510k Number | K983009 |
| Device Name: | BSM- BONE SUBSTITUTE MATERIAL |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | ETEX CORP. 350 MASSACHUSETTES AVE., 4FLR Cambridge, MA 02139 |
| Contact | Michael Schttenberg |
| Correspondent | Michael Schttenberg ETEX CORP. 350 MASSACHUSETTES AVE., 4FLR Cambridge, MA 02139 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-28 |
| Decision Date | 1998-11-25 |
| Summary: | summary |