The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Compalux Stroboscopic Light Polymerization Device.
| Device ID | K912994 |
| 510k Number | K912994 |
| Device Name: | COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | WILDE-USA, INC. P.O. BOX 4168 Naperville, IL 60567 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer WILDE-USA, INC. P.O. BOX 4168 Naperville, IL 60567 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-12-23 |