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 | K083091 |
| 510k Number | K083091 |
| Device Name: | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES |
| Classification | Device, Vascular, For Promoting 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 | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-17 |
| Decision Date | 2008-12-24 |
| Summary: | summary |