The following data is part of a premarket notification filed by Genoray Co.,ltd with the FDA for Papaya 3d Premium & Papaya 3d Premium Plus.
| Device ID | K200469 |
| 510k Number | K200469 |
| Device Name: | PAPAYA 3D Premium & PAPAYA 3D Premium Plus |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Genoray Co.,Ltd # 512, 560, Dunchon-daero, Jungwon-gu, Seongnam-si, KR 13230 |
| Contact | Hyunju Hwang |
| Correspondent | Kaitlynn Min Genoray America Inc. 147 E. Bristol Lane Orange, CA 92865 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-26 |
| Decision Date | 2020-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244061240 | K200469 | 000 |
| 08809244061233 | K200469 | 000 |