The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Biscover Led.
| Device ID | K051999 |
| 510k Number | K051999 |
| Device Name: | BISCOVER LED |
| 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 | 2005-07-25 |
| Decision Date | 2005-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757G9335P1 | K051999 | 000 |
| D757G93350 | K051999 | 000 |
| D757G9334S0 | K051999 | 000 |
| D757G93353P1 | K051999 | 000 |
| D757G933530 | K051999 | 000 |
| 10810111542064 | K051999 | 000 |