The following data is part of a premarket notification filed by Etex Corp. with the FDA for Bsm Bone Substitute Material Kit.
| Device ID | K962548 |
| 510k Number | K962548 |
| Device Name: | BSM BONE SUBSTITUTE MATERIAL KIT |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Contact | Dosuk D Lee |
| Correspondent | Dosuk D Lee ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1997-08-05 |
| Summary: | summary |