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 | K133544 |
| 510k Number | K133544 |
| Device Name: | OP300 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI 04300 |
| Contact | Terho Turkumaki |
| Correspondent | Terho Turkumaki 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 | 2013-11-18 |
| Decision Date | 2014-03-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872770 | K133544 | 000 |
| 06430035872206 | K133544 | 000 |
| 06430035872190 | K133544 | 000 |
| 06430035872183 | K133544 | 000 |
| 06430035872176 | K133544 | 000 |
| 06430035872169 | K133544 | 000 |
| 06430035872152 | K133544 | 000 |
| 06430035872107 | K133544 | 000 |
| 06430035874439 | K133544 | 000 |
| 06430035872213 | K133544 | 000 |
| 06430035872244 | K133544 | 000 |
| 06430035872251 | K133544 | 000 |
| 06430035872763 | K133544 | 000 |
| 06430035872756 | K133544 | 000 |
| 06430035872749 | K133544 | 000 |
| 06430035872732 | K133544 | 000 |
| 06430035872725 | K133544 | 000 |
| 06430035872282 | K133544 | 000 |
| 06430035872275 | K133544 | 000 |
| 06430035872268 | K133544 | 000 |
| 06430035874422 | K133544 | 000 |
Trademark Results [OP300]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OP300 97581735 not registered Live/Pending |
OPERATION 300, INC. 2022-09-07 |
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