The following data is part of a premarket notification filed by Satelec with the FDA for Mini L.e.d., Model: Mini L.e.d., Model Smartlite Mini.
| Device ID | K032465 |
| 510k Number | K032465 |
| Device Name: | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Contact | Jacqueline E Masse |
| Correspondent | Jacqueline E Masse SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2003-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190746007910 | K032465 | 000 |
| 00190746007903 | K032465 | 000 |
| 00190746007897 | K032465 | 000 |
| 03609820052519 | K032465 | 000 |
| 03609820052502 | K032465 | 000 |
| 03609820052229 | K032465 | 000 |
| 03609820052212 | K032465 | 000 |