The following data is part of a premarket notification filed by Nibec Co Ltd with the FDA for Ocs-b Collagen.
| Device ID | K142040 |
| 510k Number | K142040 |
| Device Name: | OCS-B COLLAGEN |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | NIBEC CO LTD 904 E. WINDSOR ROAD #102 Glendale, CA 91203 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam NIBEC CO LTD 904 E. WINDSOR ROAD #102 Glendale, CA 91203 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2015-07-31 |
| Summary: | summary |