The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Port-x Iv.
| Device ID | K172810 |
| 510k Number | K172810 |
| Device Name: | PORT-X IV |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | GENORAY Co., Ltd. 512, 560, Dunchon-daero, Jungwon-gu Seongnam, KR 13230 |
| Contact | Ji-yeon Choi |
| Correspondent | Chris Yoon Genoray America Inc. 147 E. Bristol Lane Orange, CA 92780 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244061226 | K172810 | 000 |
| 08809244061202 | K172810 | 000 |