The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Tulux-filter.
| Device ID | K892517 |
| 510k Number | K892517 |
| Device Name: | TULUX-FILTER |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Contact | Harold Opotow |
| Correspondent | Harold Opotow ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-08-21 |