The following data is part of a premarket notification filed by Monitex Industrial Co., Ltd. with the FDA for Bluelex.
| Device ID | K051203 |
| 510k Number | K051203 |
| Device Name: | BLUELEX |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | MONITEX INDUSTRIAL CO., LTD. 6F, 70 GUANG-FU RD., SEC 1, SAN-CHUNG CITY Taipei, TW 241-58 |
| Contact | Shu-lung Wang |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-05-11 |
| Decision Date | 2005-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14711552010012 | K051203 | 000 |