The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Biscover Lv.
| Device ID | K043168 |
| 510k Number | K043168 |
| Device Name: | BISCOVER LV |
| Classification | Coating, Filling Material, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Benjamin Lichtenwalner |
| Correspondent | Benjamin Lichtenwalner BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-16 |
| Decision Date | 2005-02-01 |
| Summary: | summary |