The following data is part of a premarket notification filed by Orquest, Inc. with the FDA for Healos Bone Graft Material.
| Device ID | K012751 |
| 510k Number | K012751 |
| Device Name: | HEALOS BONE GRAFT MATERIAL |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORQUEST, INC. 365 RAVENDALE DR. Mountain View, CA 94043 -5712 |
| Contact | Kristine F Lahman |
| Correspondent | Kristine F Lahman ORQUEST, INC. 365 RAVENDALE DR. Mountain View, CA 94043 -5712 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2001-11-14 |
| Summary: | summary |