The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. (formerly Obi Biologi with the FDA for Vitala Porcine Derived Collagen Membrane.
| Device ID | K141177 |
| 510k Number | K141177 |
| Device Name: | VITALA PORCINE DERIVED COLLAGEN MEMBRANE |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI 4620 71ST ST, BLDG 78 Lubbock, TX 79424 |
| Contact | Shane Shuttlesworth |
| Correspondent | Shane Shuttlesworth OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI 4620 71ST ST, BLDG 78 Lubbock, TX 79424 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-07 |
| Decision Date | 2015-09-15 |
| Summary: | summary |