The following data is part of a premarket notification filed by Premium Plus International Limited with the FDA for Premium Plus C01/c02 Led Curing Light.
| Device ID | K153514 |
| 510k Number | K153514 |
| Device Name: | Premium Plus C01/C02 LED Curing Light |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG, N.T. Hong Kong, CN |
| Contact | Jessica Mao |
| Correspondent | Jessica Mao PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG, N.T. Hong Kong, CN |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-08-22 |
| Summary: | summary |