The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321.
| Device ID | K100663 |
| 510k Number | K100663 |
| Device Name: | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 |
| Classification | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Applicant | Boston Scientific Corporation ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Debbie Mcintire |
| Correspondent | Debbie Mcintire Boston Scientific Corporation ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | NAJ |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-08 |
| Decision Date | 2010-04-16 |
| Summary: | summary |