The following data is part of a premarket notification filed by Invisible Technology Co., Ltd. with the FDA for Tutu 7, Model Iv-t22.
| Device ID | K062735 |
| 510k Number | K062735 |
| Device Name: | TUTU 7, MODEL IV-T22 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | INVISIBLE TECHNOLOGY CO., LTD. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Allison Scott INVISIBLE TECHNOLOGY CO., LTD. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2006-10-27 |
| Summary: | summary |