The following data is part of a premarket notification filed by Biosphere Medical with the FDA for Embosphere Microspheres.
| Device ID | K991549 |
| 510k Number | K991549 |
| Device Name: | EMBOSPHERE MICROSPHERES |
| Classification | Device, Neurovascular Embolization |
| Applicant | BIOSPHERE MEDICAL 1050 HINGHAM ST. Rockland, MA 02370 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer BIOSPHERE MEDICAL 1050 HINGHAM ST. Rockland, MA 02370 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 2000-04-26 |
| Summary: | summary |