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, Oncozene Microspheres.
| Device ID | K141209 |
| 510k Number | K141209 |
| Device Name: | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | CELONOVA BIOSCIENCES, INC. 18615 Tuscany Stone Ste 100 San Antonio, TX 78258 |
| Contact | Nicole Barber |
| Correspondent | Nicole Barber CELONOVA BIOSCIENCES, INC. 18615 Tuscany Stone Ste 100 San Antonio, TX 78258 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-09 |
| Decision Date | 2014-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810563021479 | K141209 | 000 |
| 00810563021462 | K141209 | 000 |
| 00810563021455 | K141209 | 000 |
| 00810563021448 | K141209 | 000 |
| 00810563021431 | K141209 | 000 |
| 00810563021424 | K141209 | 000 |