The following data is part of a premarket notification filed by Celonova Biosciences, Inc. with the FDA for Embozene Color-advanced Microspheres, Embozene Opaque (non-colored) Microspheres.
| Device ID | K133447 |
| 510k Number | K133447 |
| Device Name: | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES |
| Classification | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Applicant | CELONOVA BIOSCIENCES, INC. 18615 TUSCANY STONE SUITE 100 San Antonio, TX 78258 |
| Contact | Nicole Barber |
| Correspondent | Nicole Barber CELONOVA BIOSCIENCES, INC. 18615 TUSCANY STONE SUITE 100 San Antonio, TX 78258 |
| Product Code | NAJ |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-02-24 |
| Summary: | summary |