The following data is part of a premarket notification filed by Celonova Biosciences, Inc. with the FDA for Oncozene Microspheres 40um, 2ml, Oncozene Microspheres 75um, 2ml, Oncozene Microspheres 100um, 2ml, Oncozene Microsphere.
| Device ID | K130307 |
| 510k Number | K130307 |
| Device Name: | ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE |
| Classification | Device, Vascular, For Promoting Embolization |
| 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 | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2013-03-04 |
| Summary: | summary |