The following data is part of a premarket notification filed by Nibec Company, Limited with the FDA for Ocs-b.
| Device ID | K113246 |
| 510k Number | K113246 |
| Device Name: | OCS-B |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | NIBEC COMPANY, LIMITED 4568 W. 1ST STREET SUITE 104 Los Angeles, CA 90004 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam NIBEC COMPANY, LIMITED 4568 W. 1ST STREET SUITE 104 Los Angeles, CA 90004 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-02 |
| Decision Date | 2013-01-16 |
| Summary: | summary |