The following data is part of a premarket notification filed by Handpiece Headquarters - Hpr Inc. with the FDA for Maxima Electric System.
| Device ID | K180845 |
| 510k Number | K180845 |
| Device Name: | Maxima Electric System |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | Handpiece Headquarters - HPR Inc. 620 S. Placentia Avenue Placentia, CA 92870 |
| Contact | Timothy Ropchan |
| Correspondent | Sonny Phung Handpiece Headquarters - HPR Inc. 620 S. Placentia Avenue Placentia, CA 92870 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2019-07-25 |
| Summary: | summary |