The following data is part of a premarket notification filed by Monitex Industrial Co., Ltd. with the FDA for Blue Luxcer Curing Light, Models M-830, M-835 And M-855.
| Device ID | K060646 |
| 510k Number | K060646 |
| Device Name: | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | MONITEX INDUSTRIAL CO., LTD. NO. 58, FU-CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen MONITEX INDUSTRIAL CO., LTD. NO. 58, FU-CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-10 |
| Decision Date | 2006-04-21 |
| Summary: | summary |