The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Bearing Nspva Embolization Particles.
| Device ID | K130259 |
| 510k Number | K130259 |
| Device Name: | BEARING NSPVA EMBOLIZATION PARTICLES |
| Classification | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1050 HINGHAM ST Rockland, MA 02370 |
| Contact | Linda Varroso |
| Correspondent | Linda Varroso MERIT MEDICAL SYSTEMS, INC. 1050 HINGHAM ST Rockland, MA 02370 |
| Product Code | NAJ |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-01 |
| Decision Date | 2013-06-07 |
| Summary: | summary |