The following data is part of a premarket notification filed by Biosphere Medical, Inc. with the FDA for Hepasphere Microspheres.
| Device ID | K052742 |
| 510k Number | K052742 |
| Device Name: | HEPASPHERE MICROSPHERES |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | BIOSPHERE MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson BIOSPHERE MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2006-11-07 |
| Summary: | summary |