The following data is part of a premarket notification filed by Pelton & Crane with the FDA for P50 Series Dental Operative Unit And Accessories.
| Device ID | K171872 |
| 510k Number | K171872 |
| Device Name: | P50 Series Dental Operative Unit And Accessories |
| Classification | Unit, Operative Dental |
| Applicant | Pelton & Crane 11727 Fruehauf Drive Charlotte, NC 28273 |
| Contact | Frank Ray |
| Correspondent | Frank Ray Pelton & Crane 11727 Fruehauf Drive Charlotte, NC 28273 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-23 |
| Decision Date | 2018-04-26 |
| Summary: | summary |