The following data is part of a premarket notification filed by Satelec with the FDA for Mini Led Autofocus.
| Device ID | K072181 |
| 510k Number | K072181 |
| Device Name: | MINI LED AUTOFOCUS |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Steve Salesky |
| Correspondent | Steve Salesky SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2007-09-19 |
| Summary: | summary |