The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Optilux 501.
| Device ID | K020091 |
| 510k Number | K020091 |
| Device Name: | OPTILUX 501 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | KERR CORPORATION (DANBURY) 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell KERR CORPORATION (DANBURY) 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-10 |
| Decision Date | 2002-03-21 |
| Summary: | summary |