The following data is part of a premarket notification filed by Dpm Usa Corp. with the FDA for Low & High Speed Kit.
| Device ID | K090055 |
| 510k Number | K090055 |
| Device Name: | LOW & HIGH SPEED KIT |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | DPM USA CORP. 1460 NW 107 AVE. SUITE G Miami, FL 33172 |
| Contact | George Echeverri |
| Correspondent | George Echeverri DPM USA CORP. 1460 NW 107 AVE. SUITE G Miami, FL 33172 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-08 |
| Decision Date | 2009-10-27 |
| Summary: | summary |