The following data is part of a premarket notification filed by Biocompatibles U.k. Limited with the FDA for Lc Bead Microspheres, Bead Block Compressible Microspheres.
| Device ID | K094018 |
| 510k Number | K094018 |
| Device Name: | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES |
| Classification | Device, Neurovascular Embolization |
| Applicant | BIOCOMPATIBLES U.K. LIMITED 20310 SW 48TH STREET Ft. Lauderdale, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum BIOCOMPATIBLES U.K. LIMITED 20310 SW 48TH STREET Ft. Lauderdale, FL 33332 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-29 |
| Decision Date | 2010-04-16 |
| Summary: | summary |