The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Vip- Variable Intensity Polymerizer.
| Device ID | K000426 |
| 510k Number | K000426 |
| Device Name: | VIP- VARIABLE INTENSITY POLYMERIZER |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Kathryn B Patterson |
| Correspondent | Kathryn B Patterson BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-09 |
| Decision Date | 2000-04-12 |