The following data is part of a premarket notification filed by Apoza Enterprise Co. Ltd. with the FDA for Apoza Led Curing Light, Model E-morlit, D-2000, Top 3w, Top 5w.
| Device ID | K070373 |
| 510k Number | K070373 |
| Device Name: | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | APOZA ENTERPRISE CO. LTD. 2904 N. BOLDT DR. Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich APOZA ENTERPRISE CO. LTD. 2904 N. BOLDT DR. Flagstaff, AZ 86001 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-08 |
| Decision Date | 2007-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719883751324 | K070373 | 000 |
| 04719883750860 | K070373 | 000 |
| 04719883750853 | K070373 | 000 |
| 04719883750839 | K070373 | 000 |
| 04719883750549 | K070373 | 000 |
| 04719883750464 | K070373 | 000 |
| 04719883751508 | K070373 | 000 |