The following data is part of a premarket notification filed by Biocure, Inc. with the FDA for Gelspheres Embolic Agent.
| Device ID | K023089 |
| 510k Number | K023089 |
| Device Name: | GELSPHERES EMBOLIC AGENT |
| Classification | Device, Neurovascular Embolization |
| Applicant | BIOCURE, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 -1111 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum BIOCURE, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 -1111 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-17 |
| Decision Date | 2002-12-16 |
| Summary: | summary |