The following data is part of a premarket notification filed by Etex Corp. with the FDA for Cap Plus.
| Device ID | K063050 |
| 510k Number | K063050 |
| Device Name: | CAP PLUS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Contact | Frances A Florence |
| Correspondent | Frances A Florence ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-04 |
| Decision Date | 2007-11-19 |
| Summary: | summary |