The following data is part of a premarket notification filed by Planmeca Usa, Inc. with the FDA for Dental Radiographic 90, Model Pm 2002 Cc Panoramic.
| Device ID | K864474 |
| 510k Number | K864474 |
| Device Name: | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PLANMECA USA, INC. 2428 HANOVER AVE. Richmond, VA 23220 |
| Contact | Gay Jacobsen |
| Correspondent | Gay Jacobsen PLANMECA USA, INC. 2428 HANOVER AVE. Richmond, VA 23220 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-13 |
| Decision Date | 1986-11-26 |