The following data is part of a premarket notification filed by Steiner Laboratories Div Of Steiner Healthcare Llc with the FDA for Osseoconduct.
| Device ID | K101718 |
| 510k Number | K101718 |
| Device Name: | OSSEOCONDUCT |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC 590 FARRINGTON HWY., #524 SUITE 132 Kapolei, HI 96707 |
| Contact | Gregory G Steiner |
| Correspondent | Gregory G Steiner STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC 590 FARRINGTON HWY., #524 SUITE 132 Kapolei, HI 96707 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-18 |
| Decision Date | 2010-10-26 |
| Summary: | summary |