OP300
X-ray, Tomography, Computed, Dental
PALODEX GROUP OY
The following data is part of a premarket notification filed by Palodex Group Oy with the FDA for Op300.
Pre-market Notification Details
| Device ID | K122018 |
| 510k Number | K122018 |
| Device Name: | OP300 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI 04300 |
| Contact | Matti Tulikoura |
| Correspondent | Matti Tulikoura PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI 04300 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-10 |
| Decision Date | 2012-12-10 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872145 | K122018 | 000 |
| 06430035872138 | K122018 | 000 |
| 06430035872121 | K122018 | 000 |
| 06430035872114 | K122018 | 000 |
Trademark Results [OP300]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OP300 97581735 not registered Live/Pending |
OPERATION 300, INC. 2022-09-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.