The following data is part of a premarket notification filed by Biosphere Medical, Inc. with the FDA for Embogold Microsphere.
| Device ID | K010026 |
| 510k Number | K010026 |
| Device Name: | EMBOGOLD MICROSPHERE |
| Classification | Device, Neurovascular Embolization |
| Applicant | BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. Rockland, MA 02370 |
| Contact | John D Bonasera |
| Correspondent | John D Bonasera BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. Rockland, MA 02370 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-03 |
| Decision Date | 2001-06-21 |