The following data is part of a premarket notification filed by Good Doctors Co., Ltd. with the FDA for Cl-dc20, Cl-dc21.
| Device ID | K093751 |
| 510k Number | K093751 |
| Device Name: | CL-DC20, CL-DC21 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | GOOD DOCTORS CO., LTD. 5401 S. COTTONWOOD CT Greenwood Village, CO 80121 |
| Contact | Kevin Walls, Rac |
| Correspondent | Kevin Walls, Rac GOOD DOCTORS CO., LTD. 5401 S. COTTONWOOD CT Greenwood Village, CO 80121 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-07 |
| Decision Date | 2010-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800025400088 | K093751 | 000 |
| 10386040012485 | K093751 | 000 |
| 10386040012478 | K093751 | 000 |