The following data is part of a premarket notification filed by Biosphere Medical, Inc. with the FDA for Embosphere Microspheres And Embogold Microspheres For Use In Uterine Fibroid Embolization.
| Device ID | K021397 |
| 510k Number | K021397 |
| Device Name: | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION |
| Classification | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Applicant | BIOSPHERE MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Shiela Hemeon-heyer |
| Correspondent | Shiela Hemeon-heyer BIOSPHERE MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | NAJ |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-11-22 |
| Summary: | summary |