The following data is part of a premarket notification filed by Handpiece Headquarters with the FDA for Hhc Push-button Replacement Turbine For Midwest Tradition Handpiece Model Mw Turbine Replacement.
| Device ID | K100389 |
| 510k Number | K100389 |
| Device Name: | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia, CA 92870 |
| Contact | Tina Steffaine-oak |
| Correspondent | Tina Steffaine-oak HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia, CA 92870 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-08-12 |
| Summary: | summary |