The following data is part of a premarket notification filed by Handpiece Headquarters with the FDA for Maxima-m Straight Attachment, Maxima-m Contra Angle Sheath.
| Device ID | K092053 |
| 510k Number | K092053 |
| Device Name: | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia, CA 92870 |
| Contact | Tim Ropchan |
| Correspondent | Tim Ropchan HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia, CA 92870 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-07 |
| Decision Date | 2009-08-20 |
| Summary: | summary |